Intravasculaire katheters: Centraal veneuze toegang

Initiatief: NVVH Aantal modules: 15

Echogeleid aanprikken

Uitgangsvraag

Wat is de waarde van echogeleid aanprikken van een centraal veneuze of perifeer veneuze lijn bij volwassen patiënten?

Aanbeveling

Centraal veneuze katheter

Prik de vena femoralis, vena jugularis interna en vena subclavia voor het plaatsen van een centrale lijn echogeleid aan.

 

Perifere lijnen

Overweeg een perifere lijn echogeleid te prikken in geval van:

  • Niet zichtbare en niet palpabele venen; of
  • Een verleden van meer dan twee pogingen voorafgaand aan het succesvol plaatsen van de perifere lijn.

PICC-lijnen

Prik een vene in de bovenarm voor een perifeer ingebrachte centrale katheter echogeleid aan.

Overwegingen

Voor- en nadelen van de interventie en de kwaliteit van het bewijs

Er is literatuuronderzoek uitgevoerd naar de waarde van echogeleid aanprikken van een centraal veneuze of perifere lijn. De uitgangsvraag werd gevangen in drie PICO’s. PICO 1 vergeleek echogeleid aanprikken met niet-echogeleid aanprikken (ofwel aanprikken op basis van landmarks) bij patiënten die een centraal veneuze katheter kregen. PICO 2 en 3 vergeleken dezelfde interventies, waarbij PICO 2 zich richtte op patiënten die lastig te prikken zijn voor het aanbrengen van een perifere lijn en PICO 3 richtte zich op patiënten die een PICC-lijn kregen. Het succesvol inbrengen van de lijn/katheter en complicaties werden als cruciale uitkomstmaten gedefinieerd. Kwaliteit van leven, patiënttevredenheid, katheter-gerelateerde interventies, duur van inbrengen, mortaliteit en tromboflebitis werden als belangrijke uitkomstmaten gedefinieerd.

 

Er werden in totaal zeventien studies geïncludeerd in de literatuuranalyse. Vijftien gerandomiseerde studies werden geïncludeerd voor PICO 1, één systematische review en één gerandomiseerde studie voor PICO 2. Voor PICC-lijnen (PICO 3) werden geen geschikte studies gevonden.

 

Centraal veneuze katheters

Er werden vijftien studies geïncludeerd voor PICO 1. Bij het plaatsen van centraal veneuze katheters is de locatie van aanprikken van belang. Binnen deze PICO werden drie aanpriklocaties beschreven, namelijk in de vena jugularis interna, de vena subclavia en vena femoralis. De resultaten werden per aanpriklocatie uitgesplitst. Er werd een klinisch relevant verschil gevonden in het succesvol aanprikken in het voordeel van echogeleid aanprikken in de vena femoralis en succesvol aanprikken in één enkele poging in het voordeel van echogeleid aanprikken van de vena subclavia. Daarnaast werd een klinisch relevant verschil gevonden in het aantal complicaties wanneer er gebruik werd gemaakt van echogeleid aanprikken in de vena jugularis interna, vena subclavia en vena femoralis. Geen van de studies rapporteerde mortaliteitscijfers, kwaliteit van leven, patiënttevredenheid, katheter-gerelateerde interventies of tromboflebitis.

 

Perifere intraveneuze katheters

Er werden twee systematische reviews gevonden die voldeden aan de inclusiecriteria van PICO 2. In deze PICO werd gekozen voor een vergelijking bij patiënten die bekend waren met het feit dat er sprake was van een moeilijk te verkrijgen intraveneuze toegang. Dit werd gedefinieerd als het niet zichtbaar en palpabel zijn van venen of meer dan twee pogingen nodig om succesvol een perifere lijn te plaatsen of door een anesthesioloog beoordeeld als moeilijk te verkrijgen intraveneuze toegang. De systematische review van Tada (2022) includeerde zestien studies, waarvan er acht geschikt waren om op te nemen in deze richtlijnmodule. Deze acht studies richtten zich alleen op patiënten waarbij een moeilijke procedure werd verwacht. Geen van de studies rapporteerde mortaliteitscijfers, informatie over kwaliteit van leven of tromboflebitis. Er werden klinisch relevante verschillen gevonden voor succesvol aanprikken na één enkele poging en complicaties in het voordeel van echogeleid aanprikken.

 

PICC lijnen

Er is geen literatuur die de besluitvorming kan ondersteunen. De werkgroep is van mening dat PICC-lijnen in de huidige praktijk bij voorkeur altijd echogeleid geplaatst worden. De venen die het meest gebruikt worden voor het plaatsen van een PICC-lijn, de vena basilica, vena brachialis, zijn doorgaans niet of moeilijk zichtbaar wat motiveert tot het gebruik van een echo om de vene aan te prikken.

 

Waarden en voorkeuren van patiënten (en evt. hun verzorgers)

Voor patiënten is het belangrijk dat het inbrengen van een centrale of perifere lijn gepaard gaat met zo min mogelijk ongemak. Het in een keer correct inbrengen gaat gepaard met zo min mogelijk pijn, weke delenletsel/blauwe plekken en kans op complicaties. Het gebruik van de echo zorgt voor zichtbaarheid van aan te prikken vaten. Patiënten die bekend zijn met een moeilijke intraveneuze toegang hebben een voorkeur voor het gebruik van de echo bij het plaatsen van de centrale of perifere lijn.

 

Kosten (middelenbeslag)

Er is geen bewijs dat het gebruik van een echo voor het aanprikken van een vene resulteert in significant meer of minder kosten. Er is wel bewijs voor het verlagen van het aantal pogingen en het aantal complicaties bij gebruik van een echo, dit leidt tot het besparen van kosten op materiaal en interventies. Het gebruik van een echoapparaat brengt kosten met zich mee, maar vaak kan er met enkele apparaten volstaan worden voor een heel ziekenhuis voor het inbrengen van centrale en perifere lijnen.

 

Aanvaardbaarheid, haalbaarheid en implementatie

Het gebruik van een echo leidt tot een afname in het aantal puncties tot succesvolle toegang en tot een afname in complicaties. Het aanschaffen van een echoapparaat lijkt haalbaar gezien het gebruik breed geïmplementeerd is in de Nederlandse gezondheidszorg. Het leren gebruiken van een echoapparaat is haalbaar, er zijn diverse interne en externe mogelijkheden tot scholing.

 

Doordat diverse specialismen centrale en perifere lijnen plaatsen waar het gebruik van een echo ook voor andere doeleinden wordt gebruikt zal daar de implementatie eenvoudig zijn.

 

Bij het inbrengen van perifere lijnen lijkt het gebruik van een echo wel waardevol bij moeilijk te prikken patiënten. Bij perifere lijnen die veelal door verpleegkundigen worden ingebracht zal dit meer inzet en scholing nodig hebben.

 

Centraal veneuze katheter

Rationale van de aanbeveling: weging van argumenten voor en tegen de interventies

Het gebruik van een echo verhoogt de kans op het succesvol in één keer aanprikken en verlaagt waarschijnlijk de kans op complicaties bij het aanprikken van de vena jugularis interna, vena subclavia en vena femoralis voor centrale lijnen. Er zijn geen argumenten tegen echogeleid aanprikken.

 

Perifere lijnen

Rationale van de aanbeveling: weging van argumenten voor en tegen de interventies

Het gebruik van een echo lijkt de kans op het succesvol in één keer aanprikken te verhogen en leidt waarschijnlijk tot grotere patiënttevredenheid. Het effect op complicaties is onduidelijk door de zeer lage bewijskracht.  Echogeleid aanprikken van iedere perifere lijn is niet bijdragend, niet haalbaar en niet wenselijk. Bij moeilijk te prikken vaten is het te overwegen echogeleid de perifere lijn te plaatsen.

 

PICC-lijnen

Rationale van de aanbeveling: weging van argumenten voor en tegen de interventies

Er is geen literatuur die de besluitvorming kan ondersteunen. De werkgroep adviseert het gebruik van echo gezien de locatie, diepte en onzichtbaarheid van de venen in de bovenarm.

Onderbouwing

In de huidige praktijk worden perifere lijnen veelal geprikt zonder gebruik te maken van echografie of infrarood technologie. Als het niet lukt zonder deze hulpmiddelen wordt er gebruik gemaakt van echografie of infrarood technologie. Voor het inbrengen van centrale lijnen, perifeer of centraal, wordt in de praktijk veelvuldig gebruik gemaakt van echografie, zowel echogeleid inbrengen als de inzet van de echo voor bepaling van aanprik lokalisatie. Dit is echter niet vastgelegd als voorkeurstechniek. Het gebruik van echografie bij de plaatsing van perifere en centrale lijnen biedt voordelen die ondersteund worden door wetenschappelijk onderzoek. Studies tonen aan dat echogeleide technieken het risico op complicaties, zoals pneumothorax of arteriële puncties bij centrale lijnen, significant verminderen in vergelijking met de traditionele methode (blind prikken) (Hind, 2003). Daarnaast kan echografie de kans op succesvolle plaatsing mogelijk verhogen bij de eerste poging. Een nadeel van echografie is dat de apparatuur aanzienlijke investeringskosten met zich meebrengt en dat zorgverleners specifieke scholing en training nodig hebben om deze techniek effectief toe te passen. Ondanks de voordelen is er sprake van een discrepantie tussen het beschikbare bewijsmateriaal en de implementatie in de klinische praktijk. Deze kloof wordt onder meer toegeschreven aan organisatorische barrières, beperkte toegang tot apparatuur, en onvoldoende training van zorgverleners.


Voor patiënten op de intensive care wordt verwezen naar de Richtlijn Centraal veneuze lijn van de NVIC. De aanleg van een vaattoegang voor hemodialyse valt buiten de afbakening van deze richtlijn en wordt beschreven in de richtlijn ‘Vaattoegang voor hemodialyse’.

PICO 1

1. Success rate (critical)

1.1. Overall success rate

High GRADE

Ultrasound-guided placement of a central venous catheter in the internal jugular vein, subclavian vein, or femoral vein results in little to no difference in overall success rate when compared with landmark-based placement.

 

Sources: Airapetian, 2013; Benali, 2022; Ethesham, 2020; Faithi, 2016; Nazari, 2015; Oh, 2014; Palkhiwala, 2020; Rando, 2014; Riaz, 2015; Srinivasan, 2017; Subramony, 2022; Vinayagamurugan, 2021; Wang, 2020; Zhang, 2023

1.2. First attempt success rate

Moderate GRADE

Ultrasound-guided placement of a central venous catheter in the internal jugular vein, subclavian vein, or femoral vein likely results in a higher first attempt success rate of the central venous catheter when compared with landmark-based placement.

 

Sources: Benali, 2022; Faithi, 2016; Nazari, 2015; Palkhiwala, 2020; Riaz, 2015; Srinivasan, 2017; Vinayagamurugan, 2021; Wang, 2020; Zhang, 2023

2. Complications (critical)

Moderate GRADE

Ultrasound-guided placement of a central venous catheter in the internal jugular vein, subclavian vein, or femoral vein likely results in a large reduction of complications when compared with landmark-based placement.

 

Sources: Airapetian, 2013; Benali, 2022; Dolu, 2015; Ethesham, 2020; Palkhiwala, 2020; Rando, 2014; Riaz, 2015; Srinivasan, 2017; Vinayagamurugan, 2021; Wang, 2020; Zhang, 2023

3. Number of attempts (important)

No conclusions were formulated due to the absence of a definition for the minimally important difference.

 

4. Duration of the procedure

No conclusions were formulated due to the absence of a definition for the minimally important difference.

 

5. Mortality (important)

No GRADE

None of the included studies reported mortality rates after central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein. Therefore, a GRADE-conclusion could not be determined.

 

Source(s): -

6. Quality of life (important)

No GRADE

None of the included studies reported patients’ quality of life after central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein. Therefore, a GRADE-conclusion could not be determined.

 

Source(s): -

7. Patients’ satisfaction (important)

No GRADE

None of the included studies reported patients’ satisfaction after central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein. Therefore, a GRADE-conclusion could not be determined.

 

Source(s): -

8. Catheter-related interventions (important)

No GRADE

None of the included studies reported catheter-related intervention rates after central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein. Therefore, a GRADE-conclusion could not be determined.

 

Source(s): -

9. Thrombophlebitis (important)

No GRADE

None of the included studies reported thrombophlebitis rates after central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein. Therefore, a GRADE-conclusion could not be determined.

 

Source(s): -

PICO 2

1. Success rate (critical)

1.1 Overall success rate

Low GRADE

Ultrasound-guided placement of a peripheral intravenous catheter may result in little to no difference in overall successful placement when compared with landmark-based placement in patients with difficult vascular access.

 

Sources: Tada, 2022; Aponte, 2007; Bridey, 2018; Kerforne, 2012; Niishizawa, 2020; River, 2009; Stein, 2009; Weiner, 2013

1.2 First attempt success rate

Low GRADE

Ultrasound-guided placement of a peripheral intravenous catheter may result in a higher first attempt success rate when compared with landmark-based placement in patients with difficult vascular access.

 

Sources: Tada, 2022; Aponte, 2007; Bahl, 2016; Bridey, 2018; Kerforne, 2012; McCarthy, 2016a; Nishizawa, 2020; Stein, 2009; Weiner, 2013; Yalcinli, 2022

2. Complications (critical)

Very low GRADE

The evidence is very uncertain about the number of complications between of ultrasound-guided placement of a peripheral intravenous catheter when compared with landmark-based placement in patients with difficult vascular access.

 

Sources: Tada, 2022; Stein, 2009; McCarthy, 2016a; Nishizama, 2020

3. Number of attempts (important)

No conclusions were formulated due to the absence of a definition for the minimally important difference.

 

4. Duration of the procedure

No conclusions were formulated due to the absence of a definition for the minimally important difference.

 

5. Mortality (important)

No GRADE

None of the included studies reported mortality rates after peripheral intravenous catheter placement in patients with difficult vascular access. Therefore, a GRADE-conclusion could not be determined.

 

Source(s): -

6. Quality of life (important)

No GRADE

None of the included studies reported patients’ quality of life after peripheral intravenous catheter placement in patients with difficult vascular access. Therefore, a GRADE-conclusion could not be determined.

 

Source(s): -

7. Patients’ satisfaction (important)

Moderate GRADE

Ultrasound-guided placement of a peripheral intravenous catheter likely results in higher patient satisfaction when compared with landmark-based placement in patients with difficult vascular access.

 

Sources: Tada, 2022; Bridey, 2018; River, 2009; Stein, 2009; Weiner, 2013

8. Catheter-related interventions (important)

Low GRADE

Ultrasound-guided placement of a peripheral intravenous catheter may result in little to no difference in catheter-related interventions when compared with landmark-based placement in patients with difficult vascular access.

 

Source: Yalcinli, 2022

9. Thrombophlebitis (important)

No GRADE

None of the included studies reported thrombophlebitis rates after peripheral intravenous catheter placement in patients with difficult vascular access. Therefore, a GRADE-conclusion could not be determined.

 

Source(s): -

Description of studies

PICO 1: Central venous catheters (CVC)

The randomized controlled trial of Airapetian (2013) compared ultrasound-guided placement of central venous catheters with landmark-based placement of central venous catheters. Adult patients who needed jugular or femoral central venous catheter placement were included. In total, 118 patients were included. Thirty-six patients underwent ultrasound-guided central venous catheter placement. Thirty-eight patients underwent landmark-based central venous catheter placement. Twenty-one patients in the ultrasound-guidance group had the central venous catheter placed in the jugular vein, while the other fifteen patients had the central venous catheter placed in the femoral vein. Twenty-eight out of the 38 patients in the landmark-based cannulation group had the central venous catheter placed in the jugular vein. The ten other patients had the central venous catheter placed in the femoral vein. The reported outcomes in Airepetian (2013) were the success rate, complications, and the number of attempts.

 

The randomized controlled trial of Benali (2022) compared ultrasound-guided cannulation with landmark-based cannulation for central venous catheters. Adult patients requiring elective central venous catheters were included. In total, 70 patients were included. Thirty-five patients underwent ultrasound-guided central venous catheter placement and 35 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the subclavian vein. The reported outcomes in Benali (2022) were the success rate, complications, and the number of attempts.

 

The randomized controlled trial of Dolu (2015) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Adult patients requiring elective cardiovascular surgery were included. In total, 100 patients were included. Fifty patients underwent ultrasound-guided central venous catheter placement and 50 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the internal jugular vein. The reported outcomes in Dolu (2015) were the success rate, complications, and the number of attempts.

 

The randomized controlled trial of Ethesham (2020) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Adult patients who underwent major surgeries under general anaesthesia requiring central venous pressure monitoring, rapid infusion of fluids for major surgery, drug administration, and inadequate peripheral access were included. In total, 90 patients were included. Forty-five patients underwent ultrasound-guided central venous catheter placement and 45 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the internal jugular vein. The reported outcomes in Ethesham (2020) were the success rate and complications.

 

The randomized controlled trial of Faithi (2016) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Adult patients who were scheduled for cardiac surgery in the surgical ward of a general hospital were included. In total, 321 patients were included. One hundred and seventy patients underwent ultrasound-guided central venous catheter placement and 151 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the internal jugular vein. The reported outcome in Faithi (2016) was the success rate.

 

The randomized controlled trial of Nazari (2015) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Critically ill and hemodialysis patients who had indications for central venous catheter placement were included. In total, 336 patients were included. One hundred and sixty-eight patients underwent ultrasound-guided central venous catheter placement and 168 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the jugular vein. The reported outcomes in Nazari (2015) were the success rate, complications, and the number of attempts.

 

The randomized controlled trial of Oh (2014) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Adult patients who required subclavian venous catheterization for neurosurgery were included. In total, 66 patients were included. Thirty-three patients underwent ultrasound-guided central venous catheter placement and 33 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the subclavian vein. The reported outcomes in Oh (2014) were the success rate and complications.

 

The randomized controlled trial of Palkhiwala (2020) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Adult patients with ASA Grade II and III posted for major surgeries were included. In total, 60 patients were included. Thirty patients underwent ultrasound-guided central venous catheter placement and 30 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the internal jugular vein. The reported outcomes in Palkhiwala (2020) were the success rate, complications, and the number of attempts.

 

The randomized controlled trial of Rando (2014) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Critically ill patients or those that required surgery and a CVL were included. In total, 257 patients were included. One hundred and twenty-three patients underwent ultrasound-guided central venous catheter placement and 134 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the internal jugular vein. The reported outcomes in Rando (2014) were the success rate and complications.

 

The randomized controlled trial of Riaz (2015) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Adult patients who required internal jugular vein catheterization were included. In total, 200 patients were included. One hundred patients underwent ultrasound-guided central venous catheter placement and 100 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the internal jugular vein. The reported outcomes in Riaz (2015) were the success rate and complications.

 

The randomized controlled trial of Srinivasan (2017) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Adult patients who required central venous lines were included. In total, 170 patients were included. Eighty patients underwent ultrasound-guided central venous catheter placement and 90 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the internal jugular vein. The reported outcomes in Srinivasan (2017) were the success rate and complications.

 

The randomized controlled trial of Subramony (2022) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Adult patients who required assessment of administration of vasoactive drugs or large volume fluid resuscitation or patients in which there was failure to obtain the necessary peripheral venous access were included. In total, 85 patients were included. Forty-four patients underwent ultrasound-guided central venous catheter placement and 41 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the subclavian vein. The reported outcome in Subramony (2022) was the success rate.

 

The randomized controlled trial of Vinayagamurugan (2021) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Adult patients undergoing elective or emergency surgery under general anesthesia were included. In total, 188 patients were included. Ninety-four patients underwent ultrasound-guided central venous catheter placement and 94 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the internal jugular vein. The reported outcomes in Vinayagamurugan (2021) were the success rate and complications.

 

The randomized controlled trial of Wang (2020) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Adult patients, ICU inpatient, and requiring subclavian vein puncture were included. In total, 200 patients were included. One hundred patients underwent ultrasound-guided central venous catheter placement and 100 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the subclavian vein. The reported outcomes in Wang (2020) were the success rate, complications, and the number of attempts.

 

The randomized controlled trial of Zhang (2023) compared ultrasound-guided placement of central venous catheters with landmark-based placement for central venous catheters. Adult patients with right subclavian vein catheterization were included. In total, 60 patients were included. Thirty patients underwent ultrasound-guided central venous catheter placement and 30 patients underwent landmark-based central venous catheter placement. In both groups, the central venous catheter was placed in the subclavian vein. The reported outcomes in Zhang (2023) were the success rate and complications.

 

PICO 2: Peripheral intravenous catheters

The systematic (Cochrane) review of Tada (2022) compared ultrasound-guided placement of peripheral venous catheters with landmark-based placement in adult patients. Tada (2022) searched the electronic databases of the Cochrane Vascular Specialised Register, CENTRAL, Medline, Embase, CINAHL, and LILACS with the most recent searches carried out on the 29th of November 2021. In total, Tada (2022) included sixteen randomized controlled trials. For this guideline, we were only interested in studies investigating patients with difficult intravenous access. Therefore, only eight out of the sixteen studies from the systematic review of Tada (2022) were eligible for inclusion in this guideline (Aponte, 2007; Bahl, 2016; Bridey, 2018; Keforne, 2012; McCarthy, 2016; Nishizawa, 2020; Stein, 2009, Weiner, 2013). Tada (2022) used the definition of the difficulty of peripheral intravenous cannulation adopted by original studies. The reported outcomes in Tada (2022) were the success rate, complications, number of attempts, patients’ satisfaction

 

The randomized controlled trial of Yalcinli (2022) compared ultrasound-guided placement of peripheral venous catheters with landmark-based placement in adult patients with difficult vascular access (DVA). In total, 270 patients were included. For this guideline, we excluded patients allocated to near-infrared based placement (N=90) and only included patients allocated to ultrasound-guided placement (N=90) and landmark-based placement (N=90). Difficult vascular access criteria of patients were more than two attempts on previous visits, invisible veins, or anticipated difficulties. The reported outcomes in Yalcinli (2022) were the success rate and number of attempts.

 

PICO 3: Peripherally inserted central catheter (PICC)

No studies were included for PICO 3.

 

Table 1. Study characteristics of the included studies

Author

Setting

Type

Location

Difficult accessible patients yes/no?

PICO

Airapetian (2013)

Intensive care unit

Central venous catheter

Jugular and femoral vein

No information

1

Benali (2022)

Intensive care unit

Central venous catheter

Subclavian vein

Benali (2022) makes a distinction in outcomes for patients with a BMI higher and lower than 30. Benali (2022) also reports outcomes for both groups combined.

1

Dolu (2015)

Not reported

Central venous catheter

Jugular vein

Overweight patients (mean BMI is 26.6 kg/m2 vs. 25.7 kg/m2.

1

Ehtesham (2020)

Not reported

Central venous catheter

Jugular vein

No information

1

Faithi (2016)

Surgical ward of a general hospital

Central venous catheter

Jugular vein

No information

1

Nazari (2015)

Not reported

Central venous catheter

Jugular vein

No information

1

Palkhiwala (2020)

Not reported

Central venous catheter

Jugular vein

No information

1

Rando (2014)

Intensive care unit

Central venous catheter

Jugular vein

46/123 patients undergoing US guidance placement had DIVA compared to 37/134 patients undergoing landmark-based placement.

1

Riaz (2015)

Not reported

Central venous catheter

Jugular vein

No information

1

Srinivasan (2017)

Intensive care unit

Central venous catheter

Jugular vein

No information

1

Subramony (2022)

Urban tertiary teaching hospital

Central venous catheter

Subclavian vein

No information

1

Vinayagamurugan (2021)

Tertiary care university hospital

Central venous catheter

Jugular vein

No information

1

Wang (2020)

Intensive care unit

Central venous catheter

Subclavian vein

No information

1

Oh (2014)

Not reported

Central venous catheter

Subclavian vein

No information

1

Zhang (2023)

Not reported

Central venous catheter

Subclavian vein

No information

1

Yalcinli (2022)

Tertiary care hospital

Peripheral intravenous catheter

No information

Yalcinli (2022) investigated patients with difficult intravenous access, defined as: history (>two trial histories during vascular access on a previous visit), with no visible or palpable veins on the upper extremity, and who were assessed to have a difficult procedure by the senior nurse.

2

Tada (2022)

Aponte (2007): Operating room

 

Bahl (2016): Emergency department

 

Bridey (2018): Intensive care unit

 

Keforne (2012): Intensive care unit

 

McCarthy (2016): Emergency department

 

Nishizawa (2020): Intensive care unit

 

Stein (2009): Emergency department

 

Weiner (2013): Emergency department

Peripheral intravenous catheter

No information

Ten RCTs from Tada (2022) investigated patients with difficult intravenous access, defined as:

  • Aponte (2007): participants reported past difficulties or anaesthesia providers identified them as having the potential for difficulty.
  • Bahl (2016): participants reported past difficulties or experienced at least one previous episode where at least 2 attempts were required to obtain a peripheral IV.
  • Bridey (2018): could not see and palpate a vein.
  • Keforne (2012): an operator could not see and palpate the targeted vein.
  • McCarthy (2016): could not see or palpate a vein.
  • Nishizawa (2020): at least 2 failed attempts with LM, or at least 2 experienced nurses anticipated difficulty with LM based on the absence of a palpable vein or a history of difficult IV cannulation.
  • Stein (2009): at least 2 failed attempts with LM.
  • Weiner (2013): had a history of difficult IV cannulation, or at least 2 failed attempts with LM.

2

 LM: landmark-based approach

 

Results

PICO 1. Central venous catheters (CVC)

1. Success rate (critical)

1.1. Overall success rate internal jugular vein placement

The overall success rate of placement of central venous catheters in the internal jugular vein between ultrasound-guided placement and landmark-based placement was reported in nine trials (Airapetian, 2013; Ethesham, 2020; Faithi, 2016; Nazari, 2015; Palkhiwala, 2020; Rando, 2014; Riaz, 2015; Srinivasan, 2017; Vinayagamurugan, 2021). The results were pooled in a meta-analysis. The pooled success rate in the ultrasound-guided placement group was 830/841 (98.7%), compared to 788/830 (94.9%) in the landmark-based placement group. This resulted in a pooled risk ratio (RR) of 0.98 (95% CI 0.95 to 1.01), in favor of ultrasound-guided placement (figure 1.1.1). This was not considered clinically relevant.

 

1.2 Overall success rate subclavian vein placement

The overall success rate of placement of central venous catheters in the subclavian vein between ultrasound-guided placement and landmark-based placement was reported in five trials (Benali, 2022; Oh, 2014; Subramony, 2022; Wang, 2020; Zhang, 2023). The results were pooled in a meta-analysis. The pooled success rate in the ultrasound-guided placement group was 214/237 (90.3%), compared to 188/232 (81.0%) in the landmark-based placement group. This resulted in a pooled RR of 0.88 (95% CI 0.76 to 1.03), in favor of ultrasound-guided placement (figure 1.1.2). This was not considered clinically relevant.

 

1.3 Overall success rate femoral vein placement

The overall success rate of placement of central venous catheters in the femoral vein between ultrasound-guided placement and landmark-based placement was reported in one trial (Airapetian, 2013). The success rate in the ultrasound-guided placement group was 15/15 (100%), compared to 7/10 (70.0%) in the landmark-based placement group. This resulted in a pooled RR of 0.70 (95% CI 0.47 to 1.06), in favor of ultrasound-guided placement (figure 1.1.3). This was considered clinically relevant.

 

Figure 1.1.1, 1.1.2, and 1.1.3 Forest plot showing the comparison between ultrasound-guided placement and landmark-based placement for the overall success rate of central venous catheter placement in the internal jugular vein, subclavian vein, and femoral vein

Figure 111 en  112  en 113

Pooled risk ratio, random effects model. Z: p-value of overall effect; df: degrees of freedom; I2; statistical heterogeneity

 

1.4 First attempt success rate internal jugular vein placement

The first attempt success rate of placement of central venous catheters in the internal jugular vein between ultrasound-guided placement and landmark-based placement was reported in six trials (Faithi, 2016; Nazari, 2015; Palkhiwala, 2020; Riaz, 2015; Srinivasan, 2017; Vinayagamurugan, 2021). The results were pooled in a meta-analysis. The pooled success rate in the ultrasound-guided placement group was 603/652 (92.5%), compared to 477/623 (76.6%) in the landmark-based placement group. This resulted in a pooled RR of 0.82 (95% CI 0.70 to 0.95), in favor of ultrasound-guided placement (see figure 1.2.1). This was not considered clinically relevant.

 

1.5 First attempt success rate subclavian vein placement

The first attempt success rate of placement of central venous catheters in the subclavian vein between ultrasound-guided placement and landmark-based placement was reported in three trials (Benali, 2022; Wang, 2020; Zhang, 2023). The results were pooled in a meta-analysis. The pooled success rate in the ultrasound-guided placement group was 110/161 (68.3%), compared to 82/163 (50.3%) in the landmark-based placement group. This resulted in a pooled RR of 0.72 (95% CI 0.54 to 0.97), in favor of ultrasound-guided placement (see figure 1.2.2). This was considered clinically relevant.

 

1.6 First attempt success rate femoral vein

None of the included studies reported success rates on the first attempt of central venous catheter placement in the femoral vein.

 

Figure 1.2.1, 1.2.2, and 1.2.3 Forest plot showing the comparison between ultrasound-guided placement and landmark-based placement for the first attempt success rate of central venous catheter placement in the internal jugular vein, subclavian vein, and femoral vein

Figure 121 en 122 en 123

Pooled risk ratio, random effects model. Z: p-value of overall effect; df: degrees of freedom; I2; statistical heterogeneity

 

2. Complications (critical)

2.1 Complications internal jugular vein placement

Complications* due to central venous catheter placement in the internal jugular vein between ultrasound-guided placement and landmark-based placement were reported in eight trials (Airapetian, 2013; Dolu, 2015; Ethesham, 2020; Palkhiwala, 2020; Rando, 2014; Riaz, 2015; Srinivasan, 2017; Vinayagamurugan, 2021). The results were pooled in a meta-analysis. The pooled number of complications in the ultrasound-guided placement group was 42/553 (7.6%), compared to 144/561 (25.7%) in the landmark-based placement group. This resulted in a pooled RR of 0.28 (95% CI 0.16 to 0.49), in favor of ultrasound-guided placement (see figure 1.3.1). This was considered as clinically relevant.

 

2.2 Complications subclavian vein placement

Complications* due to central venous catheter placement in the subclavian vein between ultrasound-guided placement and landmark-based placement were reported in four trials (Benali, 2022; Oh, 2014; Wang, 2020; Zhang, 2023). The results were pooled in a meta-analysis. The pooled number of complications in the ultrasound-guided placement group was 10/191 (5.2%), compared to 42/193 (21.8%) in the landmark-based placement group. This resulted in a pooled RR of 0.26 (95% CI 0.13 to 0.51), in favor of ultrasound-guided placement (see figure 1.3.2). This was considered as clinically relevant.

 

2.3 Complications femoral vein placement

Complications* because of central venous catheter placement in the femoral vein between ultrasound-guided placement and landmark-based placement were reported in one trial (Airapetian, 2013). The number of complications in the ultrasound-guided placement group was 0/15 (0%), compared to 2/10 (20.0%) in the landmark-based placement group. This resulted in a pooled RR of 0.14 (95% CI 0.01 to 2.60), in favor of ultrasound-guided placement (see figure 1.3.3). This was considered as clinically relevant.

 

*Reported complications were mechanical complications, hematomas, arterial punctures, pneumothoraxes, malposition, carotid artery punctures, double wall punctures, and irritation of the brachial plexus.

 

Figure 1.3.1, 1.3.2, and 1.3.3 Forest plot showing the comparison between ultrasound-guided placement and landmark-based placement for the overall complication rates of central venous catheter placement in the internal jugular vein, subclavian vein, and femoral vein

Figure 131 en 132 en 133

Pooled risk ratio, random effects model. Z: p-value of overall effect; df: degrees of freedom; I2; statistical heterogeneity

 

 

3. Number of attempts (important)

3.1 Number of attempts in the internal jugular vein

The number of attempts for placement of a central venous catheter in the internal jugular vein was reported in three trials (Dolu, 2015; Nazari, 2015; Palkhiwala, 2020). Dolu (2015) reported the mean (SD) number of needles passes. Nazari (2015) reported the number of patients who required more than one attempt. Palkhiwala (2015) reported the mean (SD) number of attempts.

 

The mean (SD) number of needles passes for placement of a central venous catheter in the internal jugular vein in the study of Dolu (2015) in the ultrasound-guided placement group was 1.1 (0.5) needles, compared to 2.2 (1.6) needles in the landmark-based placement group. This resulted in a MD of -1.10 (95% CI -1.56 to -0.64), in favor of ultrasound-guided placement.

 

The mean (SD) number of patients who required more than one attempt of placement of a central venous catheter in the internal jugular vein in the study of Nazari (2015) in the ultrasound-guided placement group was 22/168 (13.1%), compared to 75/168 (44.6%). This resulted in a RR of 0.29 (95% CI 0.19 to 0.45), in favor of ultrasound-guided placement.

 

The mean (SD) number of attempts of placement of a central venous catheter in the internal jugular vein in the study of Palkhiwala (2020) in the ultrasound-guided placement group was 1.06 (0.24) compared to 1.43 (0.66). This resulted in a MD of -0.37 (95% CI -0.62 to -0.12) attempts, in favor of ultrasound-guided placement.

 

3.2 Number of attempts in the subclavian vein

The number of attempts for placement of a central venous catheter in the subclavian vein was reported in two trials (Benali, 2022; Wang, 2020). Benali (2022) reported the median (IQR) number of attempts. Wang (2020) reported the mean (SD) number of punctures.

 

The median (IQR) number of attempts for placement of a central venous catheter in the subclavian vein in the study of Benali (2022) in the ultrasound-guided placement group was 1.0 (IQR: 1.0 to 1.0), compared to 2.0 (IQR: 1.0 to 4.0) in the landmark-based placement group.

 

The mean (SD) number of attempts of placement of a central venous catheter in the subclavian vein in the study of Wang (2020) in the ultrasound-guided placement group (N = 96) was 1.6 (1.0) compared to 1.5 (0.7) in the landmark-based placement group (N=98). This resulted in a MD of 0.10 (95% CI -0.14 to 0.34), in favor of landmark-based placement.

 

3.3 Number of attempts in the femoral vein

None of the included studies reported the number of attempts for central venous catheter placement in the femoral vein.

 

4. Duration of the procedure (important)

The duration of the procedures was reported in eight trials (Dolu, 2015; Ethasham, 2020; Faithi, 2016; Nazari, 2015; Palkhiwala, 2020; Riaz, 2015; Vinayagamurugan, 2021; Wang, 2020; Zhang, 2023). Ethasham (2020) reported the mean duration of the procedure in minutes. Dolu (2015), Faithi (2016), Palkhiwala (2020), Riaz (2015), Vinayagamurugan (2021), and Wang (2020) reported the mean (SD) duration of the procedure in seconds and were also pooled in a second meta-analysis. Zhang (2023) only reported the mean duration of the procedure in minutes without reporting a standard deviation and was therefore reported descriptively.

 

4.1 Duration of the procedure in the internal jugular vein (in minutes)

One trial reported duration of the procedure for placement of a central venous catheter in minutes in the internal jugular vein (Ethesham, 2020). The mean (SD) duration of placement of a central venous catheter in the internal jugular vein in the ultrasound-guided placement group (N=45) was 4.2 (0.4) minutes, compared to 4.7 (0.8) minutes in the landmark-based placement group (N=45). This resulted in a mean difference (MD) of -0.50 (95% CI -0.76 to -0.24) minutes.

 

4.2 Duration of the procedure in the Internal jugular vein (in seconds)

Six trials reported duration of the procedure for placement of a central venous catheter in minutes between ultrasound-guided placement (N=612) and landmark-based placement (N=593) in the internal jugular vein (Dolu, 2015; Faithi, 2016; Nazari, 2015; Palkhiwala, 2020; Riaz, 2015; Vinayagamurugan, 2021). The results were pooled in a meta-analysis. The pooled mean difference (MD) for placement of a central venous catheter in the internal jugular vein was -36.65 (95% CI -54.57 to -18.73) seconds (see figure 1.4.1), in favor of ultrasound-guided placement.

 

4.3 Duration of the procedure in the subclavian vein (in seconds)

One trial reported duration of the procedure for placement of a central venous catheter in seconds in the subclavian vein (Wang, 2020). The mean (SD) duration of placement of a central venous catheter in the subclavian vein in the ultrasound-guided placement group (N=96) was 50 (47) seconds, compared to 62 (53) seconds in the landmark-based placement group (N=98). This resulted in a mean difference (MD) of -12.00 (95% CI -26.09 to 2.09) seconds (see figure 1.4.2).

 

Zhang (2023) only reported the mean duration of placement of central venous catheters in the subclavian vein between ultrasound-guided placement and landmark-based placement without a standard deviation and/or confidence interval. Duration of the procedure in the ultrasound-guided placement group was 6.3333 minutes, compared to 11.3667 minutes in the landmark-based placement group.

 

Figure 1.4.1, 1.4.2, and 1.4.3 Forest plot showing the comparison between ultrasound-guided placement and landmark-based placement for the duration of the procedure of central venous catheter placement in the internal jugular vein, subclavian vein, and femoral vein

Figure 141 en 142 en 143

Pooled relative risk ratio, random effects model. Z: p-value of overall effect; df: degrees of freedom; I2; statistical heterogeneity

 

4.4 Duration of the procedure in the femoral vein

None of the included studies reported the duration of the procedure for placement of central venous catheter placement in the femoral vein.

 

5 Mortality (important)

None of the included studies reported mortality rates for central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein.

 

6. Quality of life (important)

None of the included studies reported information regarding quality of life for central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein.

 

7. Patients’ satisfaction (important)

None of the included studies reported information regarding patient’s satisfaction for central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein.

 

8. Catheter-related interventions (important)

None of the included studies reported catheter-related intervention rates for central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein.

 

9. Thrombophlebitis (important)

None of the included studies reported thrombophlebitis rates for central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein.

 

Level of evidence of the literature

1. Success rate (critical)

1.1. Overall success rate

The level of evidence regarding the outcome overall success rate of central venous catheter placement in the internal jugular vein, subclavian vein, and femoral vein was derived from randomized controlled trials and therefore started high. The level of evidence was not downgraded. The level of evidence was considered as high.

 

1.2. First attempt success rate

The level of evidence regarding the outcome first attempt success rate of central venous catheter placement in the internal jugular vein, subclavian vein, and femoral vein was derived from randomized controlled trials and therefore started high. The level of evidence was downgraded by one level because of the wide confidence interval crossing the lower threshold of clinical relevance (imprecision, -1). The level of evidence was considered as moderate.

 

2. Complications (critical)

The level of evidence regarding the outcome complications because of central venous catheter placement in the internal jugular vein was derived from randomized controlled trials and therefore started high. The level of evidence was downgraded by one level because of heterogeneity in the definition of the outcome measure complications between the included studies (inconsistency, -1). The level of evidence was considered as moderate.

 

3. Number of attempts (important)

The evidence could not be graded due to the absence of a definition for the minimally important difference.

 

4. Duration of the procedure (important)

The evidence could not be graded due to the absence of a definition for the minimally important difference.

 

5. Mortality (important)

None of the included studies reported mortality rates of central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein. Therefore, the level of evidence could not be determined.

 

6. Quality of life (important)

None of the included studies reported patients’ quality of life after central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein. Therefore, the level of evidence could not be determined.

 

7. Patients’ satisfaction (important)

None of the included studies reported patients’ satisfaction after central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein. Therefore, the level of evidence could not be determined.

 

8. Catheter-related interventions (important)

None of the included studies reported catheter-related intervention rates after central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein. Therefore, the level of evidence could not be determined.

 

9. Thrombophlebitis (important)

None of the included studies reported thrombophlebitis rates of central venous catheter placement in the internal jugular vein, subclavian vein, or femoral vein. Therefore, the level of evidence could not be determined.

 

Table 2. Summary of findings PICO 1

Outcome

Ultrasound-guided placement

n/N (%) / mean (SD) / median (IQR)

Landmark-based placement

n/N (%) / mean (SD) / median (IQR)

Relative risk ratio (RR) (95% CI) / Mean difference (MD) (95% CI)

Number of trials

Difference considered clinically relevant?

1.1 Overall success rate internal jugular vein placement

830/841 (98.7%)

788/830 (94.9%)

RR 0.98 (95% CI 0.95 to 1.01)

N = 9

No

1.2 Overall success rate internal subclavian vein placement

214/237 (90.3%)

188/232 (81.0%)

RR 0.88 (95% CI 0.76 to 1.03)

N = 5

No

1.3 Overall success rate femoral vein placement

15/15 (100%)

7/10 (70.0%)

RR 0.70 (95% CI 0.47 to 1.06)

N = 1

Yes

1.4 First attempt success rate internal jugular vein placement

603/652 (92.5%)

477/623 (76.6%)

RR 0.82 (95% CI 0.70 to 0.95)

N = 6

No

1.5 First attempt success rate subclavian vein placement

110/161 (68.3%)

82/163 (50.3%)

RR 0.72 (95% CI 0.54 to 0.97)

N = 3

Yes

1.6 First attempt success rate femoral vein placement

No data.

No data.

Not applicable.

Not applicable.

Not applicable.

2.1 Complications internal jugular vein placement

42/553 (7.6%)

144/561 (25.7%)

RR 0.28 (95% CI 0.16 to 0.49)

N = 8

Yes

2.2 Complications subclavian vein placement

10/192 (5.2%)

42/193 (21.8%)

RR 0.26 (95% CI 0.13 to 0.51

N = 4

Yes

2.3 Complications femoral vein placement

0/15 (0%)

2/10 (20.0%)

RR 0.14 (95% CI 0.01 to 2.60)

N = 1

Yes

3.1 Number of attempts in the internal jugular vein

 

22/168 (13.1%) who required more than one attempt

 

1.1 (0.5) needles passes for placement of a central venous catheter

 

 

1.06 (0.24) attempts

 

75/168 (44.6%) who required more than one attempts

 

2.2 (1.6) needles passes for placement of a central venous catheter

 

 

 

1.43 (0.66) attempts

RR 0.29 (95% CI 0.19 to 0.45)

 

 

MD -1.10 (95% CI -1.56 to -0.64)

 

 

 

 

 

MD 0.37 (95% CI -0.62 to -0.12)

N = 1

 

 

 

N = 1

 

 

 

 

 

 

N =1

Yes

 

 

 

Not applicable.

 

 

 

 

 

 

Not applicable.

3.2 Number of attempts in the subclavian vein

Median 1.0 (IQR 1.0 to 1.0)

 

 

1.6 (1.0) attempts

Median 2.0 (IQR 1.0 to 4.0)

 

 

1.5 (0.7) attempts

Not applicable.

 

 

MD -0.10 (95% CI -0.14 to 0.34)

N = 1

 

 

 

N = 1

Not applicable.

 

 

 

No

3.3 Number of attempts in the femoral vein

No data.

No data.

Not applicable.

Not applicable.

Not applicable.

4.1 Duration of the procedure in the internal jugular vein

4.2 (0.4) minutes

4.7 (0.8) minutes

MD -0.50 (95% CI -0.76 to -0.24)

 

Pooled MD -36.65 (95% CI -54.47 to -18.73) seconds

N = 1

 

 

N = 6

Not applicable.

 

 

Not applicable.

4.2 Duration of the procedure in the subclavian vein

50 (47) seconds

62 (53) seconds

MD -12.00 (95% CI -26.09 to 2.09)

N = 1

Not applicable.

4.3 Duration of the procedure in the femoral vein

No data.

No data.

Not applicable.

Not applicable.

Not applicable.

  1. Mortality

No data.

No data.

Not applicable.

Not applicable.

Not applicable.

  1. Quality of life

No data.

No data.

Not applicable.

Not applicable.

Not applicable.

  1. Patients’ satisfaction

No data.

No data.

Not applicable.

Not applicable.

Not applicable.

  1. Catheter-related interventions

No data.

No data.

Not applicable.

Not applicable.

Not applicable.

  1. Thrombophlebitis

No data.

No data.

Not applicable.

Not applicable.

Not applicable.

PICO 2: Peripheral intravenous catheters

1. Success rate (critical)

1.1 Overall success rate

The overall success rate of placement of peripheral intravenous catheter placement between ultrasound-guided placement and landmark-based placement in patients with difficult vascular access was reported in seven trials included in the systematic review of Tada (2022) (Aponte, 2007; Bridey, 2018; Kerforne, 2012; Nishizawa, 2020; River, 2009; Stein, 2009; Weiner, 2013). The results were pooled in a meta-analysis. The pooled overall success rate in the ultrasound-guided placement group was 171/220 (77.7%), compared to 134/208 (64.4%) the landmark-based placement group. This resulted in a pooled RR of 0.84 (95% CI 0.69 to 1.02), in favor of ultrasound-guided placement (see figure 2). This was not considered clinically relevant.

 

Figure 2. Forest plot showing the comparison between ultrasound-guided placement and landmark-based placement for the overall success rate of peripheral intravenous catheter placement in patients with difficult vascular access

Figure 2 van PICO 2 M6

Pooled risk ratio, random effects model. Z: p-value of overall effect; df: degrees of freedom; I2; statistical heterogeneity

 

1.2 First attempt success rate

The first attempt success rate of placement of peripheral intravenous catheter in patients with difficult vascular access between ultrasound-guided placement and landmark-based placement was reported in eight trials included in the systematic review of Tada (2022) (Aponte, 2007; Bahl, 2016; Bridey, 2018; Kerforne, 2012; McCarthy, 2016a; Nishizawa, 2020; Stein, 2009; Weiner, 2013) and in one additional trial (Yalcinli, 2022). The results were pooled in a meta-analysis. The pooled first attempt success rate in the ultrasound-guided placement group was 300/445 (67.4%), compared to 190/430 (44.1%) in the landmark-based placement group. This resulted in a pooled RR of 0.69 (95% CI 0.55 to 0.86), in favor of ultrasound-guided placement (see figure 3). This was considered clinically relevant.

 

Figure 3. Forest plot showing the comparison between ultrasound-guided placement and landmark-based placement for the first attempt success rate of peripheral intravenous catheter placement in patients with difficult vascular access

Figure 3 PICO 2 M6

Pooled risk ratio, random effects model. Z: p-value of overall effect; df: degrees of freedom; I2; statistical heterogeneity

 

2. Complications (critical)

Complications because of peripheral intravenous catheter placement in patients with difficult vascular access between ultrasound-guided placement and landmark-based placement were reported in three trials included in the systematic review of Tada (2022) (Stein, 2009; McCarthy, 2016a; Nishizawa, 2020). The results were pooled in a meta-analysis. The pooled number of complications in the ultrasound-guided placement group was 7/156 (4.5%), compared to 9/155 (5.8%) in the landmark-based placement group. This resulted in a pooled RR of 0.76 (95% CI 0.29 to 1.96), in favor of ultrasound-guided placement (see figure 4). This was considered as clinically relevant. Complications were not further specified.

 

Figure 4. Forest plot showing the comparison between ultrasound-guided placement and landmark-based placement for complication rate of peripheral intravenous catheter placement in patients with difficult vascular access

Figure 4 PICO2 M6

Pooled risk ratio, random effects model. Z: p-value of overall effect; df: degrees of freedom; I2; statistical heterogeneity

 

3. Number of attempts (important)

The number of attempts for placement of a peripheral intravenous catheter in patients with difficult vascular access was reported in seven trials included in the systematic review of Tada (2022) (Aponte, 2007; Bahl, 2016; Bridey, 2018; Pappas, 2006; River, 2009; Stein, 2009; Weiner, 2013) and in one additional trial (Yalcinli, 2022). The results of these studies, except for Yalcinli (2022), were pooled in a meta-analysis. The pooled mean difference (MD) in number of attempts between ultrasound-guided (N=235) and landmark-based placement (N=213) of a peripheral intravenous catheter was -0.17 (95% CI -0.36 to 0.03) attempts (see figure 5).

 

Figure 5. Forest plot showing the comparison between ultrasound-guided placement and landmark-based placement for number of attempts of peripheral intravenous catheter placement in patients with difficult vascular access

Figure 6 PICO 2 M6

Pooled mean difference, random effects model. Z: p-value of overall effect; df: degrees of freedom; I2; statistical heterogeneity

 

Yalcinli (2022) reported the median (IQR) number of attempts and could therefore not be pooled in the meta-analysis. The median (IQR) number of attempts of peripheral intravenous catheter placement in the ultrasound-guided placement group (N=90) was 1.0 (1.0 to 1.0) attempts, compared to 1.0 (IQR 1.0 to 2.0) seconds in the landmark-based placement group.

 

4. Duration of the procedure (important)

The duration of the procedures was reported in two trials (Aponte, 2007; McCarthy, 2016a). The results were pooled in a meta-analysis. The pooled MD between ultrasound-guided placement (N=112) and landmark-based placement (N=107) of a peripheral intravenous catheter was 119.85 (95% CI 88.64 to 151.05) seconds.

 

Figure 6. Forest plot showing the comparison between ultrasound-guided placement and landmark-based placement for duration of the procedure of peripheral intravenous catheter placement in patients with difficult vascular access

Figure 7 PICO 2 M6

Pooled mean difference, random effects model. Z: p-value of overall effect; df: degrees of freedom; I2; statistical heterogeneity

 

5. Mortality (important)

None of the included studies reported mortality rates for peripheral intravenous catheter placement in patients with difficult intravenous access.

 

6. Quality of life (important)

None of the included studies reported information regarding quality of life for peripheral intravenous catheter placement in patients with difficult vascular access.

 

7. Patient satisfaction (important)

Patient satisfaction was reported in four trials from the systematic review of Tada (2022) (Bridey, 2018; River, 2009; Stein, 2009; Weiner, 2013). Patient satisfaction was measured on a numeric rating scale from zero to ten or a four-step Likert scale. The higher the score, the higher the level of satisfaction. The results were pooled in a meta-analysis. The pooled standardized MD in patient satisfaction between ultrasound-guided (N=141) and landmark-based placement (N=132) of peripheral intravenous catheters was -0.25 (95% CI -0.50 to -0.01), in favor of ultrasound-guided placement (see figure 7). This was not considered as clinically relevant.

 

Figure 7. Forest plot showing the comparison between ultrasound-guided placement and landmark-based placement for patient’s satisfaction of peripheral intravenous catheter placement in patients with difficult vascular access

Figure 8 PICO 2 M6

Pooled mean difference, random effects model. Z: p-value of overall effect; df: degrees of freedom; I2; statistical heterogeneity

 

8. Catheter-related interventions (important)

Catheter-related interventions rates due to ultrasound-guided or landmark-based placement of peripheral intravenous catheters in patients with difficult vascular access were reported in one trial (Yalcinli, 2022). Yalcinli (2022) defined catheter-related interventions as ‘need for rescue methods’. The number of patients who required catheter-related interventions in the ultrasound-guided placement group was 17/90 (18.9%), compared to 17/90 (18.9%) in the landmark-based placement group. This resulted in a RR of 1.00 (95% CI 0.55 to 1.83), not in favor of one of the groups. This was not considered as clinically relevant.

 

9. Thrombophlebitis (important)

None of the included studies reported thrombophlebitis rates for peripheral intravenous catheter placement in patients with difficult vascular access.

 

Level of evidence of the literature

1. Success rate (critical)

1.1 Overall success rate

The level of evidence regarding the outcome overall success rate of peripheral intravenous catheter placement in patients with difficult vascular access was derived from randomized controlled trials and therefore started high. The level of evidence was downgraded by one level because of the wide confidence interval crossing the lower threshold of clinical relevance (imprecision, -1). The level of evidence was considered as moderate.

 

1.2 First attempt success rate

The level of evidence regarding the outcome first attempt success rate of peripheral intravenous catheter placement in patients with difficult vascular access was derived from randomized controlled trials and therefore started high. The level of evidence was downgraded by two levels because of the wide confidence interval crossing the lower threshold of clinical relevance (imprecision, -1). The level of evidence was considered as moderate.

 

2. Complications (critical)

The level of evidence regarding the outcome complications of peripheral intravenous catheter placement in patients with difficult vascular access was derived from randomized controlled trials and therefore started high. The level of evidence was downgraded by three levels because of the wide confidence interval crossing both thresholds of clinical relevance (imprecision, -3). The level of evidence was considered as very low.

 

3. Number of attempts (important)

The evidence could not be graded due to the absence of a definition for the minimally important difference.

 

4. Duration of the procedure (important)

The evidence could not be graded due to the absence of a definition for the minimally important difference.

 

5. Mortality (important)

None of the included studies reported mortality rates of peripheral intravenous catheter placement in patients with difficult vascular access. Therefore, the level of evidence could not be determined.

 

6. Quality of life (important)

None of the included studies reported patient’s quality of life after peripheral intravenous catheter placement in patients with difficult vascular access. Therefore, the level of evidence could not be determined.

 

7. Patients’ satisfaction (important)

The level of evidence regarding the outcome first attempt success rate of peripheral intravenous catheter placement in patients with difficult vascular access was derived from randomized controlled trials and therefore started high. The level of evidence was downgraded by two levels because of the small number of included patients (imprecision, -1). The level of evidence was considered as moderate.

 

8. Catheter-related interventions (important)

The level of evidence regarding the outcome first attempt success rate of peripheral intravenous catheter placement in patients with difficult vascular access was derived from randomized controlled trials and therefore started high. The level of evidence was downgraded by two levels because of the wide confidence interval crossing both thresholds of clinical relevance (imprecision, -2). The level of evidence was considered as low.

 

9. Thrombophlebitis (important)

None of the included studies reported thrombophlebitis rates of peripheral intravenous catheter placement in patients with difficult vascular access. Therefore, the level of evidence could not be determined.

 

Table 3. Summary of findings PICO 2

Table 3 Summary of findings PICO 2 CVT

PICO 3. Peripherally inserted central catheter (PICC)

No studies were included that reported outcomes between ultrasound-guided placement and landmark-guided placement for peripherally inserted central catheters.

A systematic review of the literature was performed to answer the following questions:

  • What are the benefits and harms of ultrasound-guided placement in comparison with landmark-based placement in adult patients receiving a central venous catheter?
  • What are the benefits and harms of ultrasound-guided placement in comparison with landmark-based placement in adult patients receiving a peripheral intravenous catheter?
  • What are the benefits and harms of ultrasound-guided placement in comparison with landmark-based placement in adult patients receiving a peripherally inserted central catheter?

PICO 1. Central venous catheters (CVC)

P: Adult patients receiving a central venous catheter
I: Ultrasound-guided placement
C: Landmark-based placement
O: Success rate, procedure duration, complications, quality of life, patient satisfaction, catheter-related interventions per time, mortality, thrombophlebitis

PICO 2. Peripheral intravenous catheters

P:

Adult patients with difficult venous access receiving a peripheral intravenous catheter

I:

Ultrasound-guided placement

C:

Landmark-based placement

O: Success rate, procedure duration, complications, quality of life, patient satisfaction, catheter-related interventions per time, mortality, thrombophlebitis

PICO 3: Peripherally inserted central catheter (PICC)

P:

Adult patients receiving a peripherally inserted central catheter

I:

Ultrasound-guided placement

C:

Landmark-based placement

O: Success rate, procedure duration, complications, quality of life, patient satisfaction, catheter-related interventions per time, mortality, thrombophlebitis

Relevant outcome measures

The guideline development group considered complications and success rate as critical outcomes for decision making; and procedure duration, quality of life, patient satisfaction, catheter-related interventions, mortality, and thrombophlebitis as important outcomes for decision making.

 

The working group defined a threshold of 10% for continuous outcomes, a relative risk (RR) for dichotomous outcomes of <0.80 and >1.25, or a difference of 0.5 standard deviations for standardized mean differences (SMD) as minimal clinically (patient) important differences. For procedure duration and number of attempts, no minimal important differences were defined.

 

Search and select (Methods)

The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until the 7th of February 2024. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 721 hits. Studies were selected based on the following criteria: Systematic reviews and randomized controlled trials on ultrasound-guided puncturing of a central venous or peripheral line. Twenty-nine studies were initially selected based on title and abstract screening. After reading the full text, twelve studies were excluded (see the table with reasons for exclusion under the tab Methods) and seventeen studies were included.

 

Results

Seventeen studies were included in the analysis of the literature. Fifteen studies for PICO 1 and two studies for PICO 2. No studies were included for PICO 3. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.

  1. Airapetian N, Maizel J, Langelle F, Modeliar SS, Karakitsos D, Dupont H, Slama M. Ultrasound-guided central venous cannulation is superior to quick-look ultrasound and landmark methods among inexperienced operators: a prospective randomized study. Intensive Care Med. 2013 Nov;39(11):1938-44. doi: 10.1007/s00134-013-3072-z. Epub 2013 Sep 12. PMID: 24026296.
  2. Benali M, Trabelsi B, Abdouli H, Yedes A, Elhadj Kacem H, Fki M. Ultrasound guidance versus anatomical landmarks for subclavian vein catheterization: a prospective study. Tunis Med. 2022 juillet;100(7):520-524. PMID: 36571740; PMCID: PMC9703904.
  3. Dolu H, Goksu S, Sahin L, Ozen O, Eken L. Comparison of an ultrasound-guided technique versus a landmark-guided technique for internal jugular vein cannulation. J Clin Monit Comput. 2015 Feb;29(1):177-82. doi: 10.1007/s10877-014-9585-3. Epub 2014 May 18. PMID: 24838550.
  4. Ehtesham, Atiyah & Patkar, Charushila & Phalgune, Deepak. (2020). Study between Ultrasound Guided Technique and Conventional Landmark Technique for Internal Jugular Vein Cannulation: A Randomised Controlled Trial. JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH. 14. 10.7860/JCDR/2020/43578.13597.
  5. Fathi M, Izanloo A, Jahanbakhsh S, Taghavi Gilani M, Majidzadeh A, Sabri Benhangi A, Paravi N. Central Venous Cannulation of the Internal Jugular Vein Using Ultrasound-Guided and Anatomical Landmark Techniques. Anesth Pain Med. 2016 May 9;6(3):e35803. doi: 10.5812/aapm.35803. PMID: 27642580; PMCID: PMC5018146.
  6. Nazari I, Musavi M, Alavi M. Comparing Outcomes and Complication of Central Venous Cannulation Using Both Conventional and Ultrasound Guide. Biosci Biotechnol Res Asia 2015;12(3).
  7. Oh AY, Jeon YT, Choi EJ, Ryu JH, Hwang JW, Park HP, Do SH. The influence of the direction of J-tip on the placement of a subclavian catheter: real time ultrasound-guided cannulation versus landmark method, a randomized controlled trial. BMC Anesthesiol. 2014 Feb 28;14:11. doi: 10.1186/1471-2253-14-11. PMID: 24581318; PMCID: PMC3975933.
  8. Rando K, Castelli J, Pratt JP, Scavino M, Rey G, Rocca ME, Zunini G. Ultrasound-guided internal jugular vein catheterization: a randomized controlled trial. Heart Lung Vessel. 2014;6(1):13-23. PMID: 24800194; PMCID: PMC4009593.
  9. Riaz A, Shan Khan RA, Salim F. Ultrasound guided internal jugular venous cannulation: comparison with land-mark technique. J Coll Physicians Surg Pak. 2015 May;25(5):315-9. PMID: 26008653.
  10. Srinivasan S, Govil D, Gupta S, Patel S, Jagadeesh KN, Tomar DS. Incidence of posterior wall penetration during internal jugular vein cannulation: A comparison of two techniques using real-time ultrasound. Indian J Anaesth. 2017 Mar;61(3):240-244. doi: 10.4103/ija.IJA_632_16. PMID: 28405038; PMCID: PMC5372405.
  11. Subramony R, Spann R, Medak A, Campbell C. Ultrasound-Guided vs. Landmark Method for Subclavian Vein Catheterization in an Academic Emergency Department. J Emerg Med. 2022 Jun;62(6):760-768. doi: 10.1016/j.jemermed.2021.11.002. Epub 2022 May 11. PMID: 35562246.
  12. Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2. PMID: 36507736; PMCID: PMC9744071.
  13. Vinayagamurugan A, Badhe AS, Jha AK. Comparison of external jugular vein-based surface landmark approach and ultrasound-guided approach for internal jugular venous cannulation: A randomised crossover clinical trial. Int J Clin Pract. 2021 Mar;75(3):e13783. doi: 10.1111/ijcp.13783. Epub 2020 Nov 13. PMID: 33095965.
  14. Wang Q, Cai J, Lu Z, Zhao Q, Yang Y, Sun L, He Q, Xu S. Static Ultrasound Guidance VS. Anatomical Landmarks for Subclavian Vein Puncture in the Intensive Care Unit: A Pilot Randomized Controlled Study. J Emerg Med. 2020 Dec;59(6):918-926. doi: 10.1016/j.jemermed.2020.07.039. Epub 2020 Sep 22. PMID: 32978029.
  15. Yalçınlı S, Karbek Akarca F, Can Ö, Uz İ, Konakçı G. Comparison of Standard Technique, Ultrasonography, and Near-Infrared Light in Difficult Peripheral Vascular Access: A Randomized Controlled Trial. Prehosp Disaster Med. 2022 Feb;37(1):65-70. doi: 10.1017/S1049023X21001217. Epub 2021 Dec 6. PMID: 34865664.
  16. Zhang YS, Zhang SL, Guo WM, Liu T, Ma YJ. Clinical Effect of Modified Ultrasound-Guided Subclavian Vein Puncture. Int J Clin Pract. 2023 Jul 6;2023:5534451. doi: 10.1155/2023/5534451. PMID: 37457808; PMCID: PMC10344633.

Systematic review(s) PICO 1

Niet van toepassing.

 

Systematic review(s) PICO 2

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

 

Follow-up

Outcome measures and effect size

Comments

Tada (2022)

SR and meta-analysis of RCTs

 

Literature search up to the 29th of November 2021.

 

A: Aponte (2007)

B: Bahl (2016)

C: Bridey (2018)

D: Costantino (2005)

E: Glasin (2020)

F: Ismailoglu (2015)
G: Kerforne (2012)
H: McCarthy (2016A)

I: McCarthy (2016B)
J: McCarthy (2016C)

K: Nishizama (2020)

L: Pappas (2006)

M: River (2009)

N: Skulec (2019)

O: Stein (2009)

P: Weiner (2013)

 

Study design:

A: RCT

B: RCT

C: RCT

D: RCT

E: RCT

F: RCT
G: RCT

H: RCT

I: RCT

J: RCT

K: RCT

L: RCT

M: RCT

N: RCT

O: RCT

P: RCT

 

Setting and Country:

A: Operating room

B: Emergency department

C: ICU

D: Emergency department

E: Emergency department

F: Emergency department
G: ICU

H: Emergency department

I: Emergency department

J: Emergency department

K: ICU

L: Operating room

M: Emergency department

N: Prehospital

O: Emergency department

P: Emergency department

 

Source of funding and conflicts of interest:

MT: declared that his institute received research grants from Nakatani Foundation (ongoing multicentre prospective cohort study for myocardial infarction in the emergency department) and Radiometer America, Inc. (ongoing multicentre prospective cohort study of myocardial infarction in the emergency department). MT declared that he has received royalties from Japan Medical Journal as he coauthored a textbook about ultrasound-guided peripheral intravenous cannulation in emergency medicine. The textbook is about the technical issues of the review intervention. It explains the review intervention as one of various options and is not intended to promote the review intervention. Japan Medical Journal has no role in this Cochrane Review and meta-analysis. NY: none known TM: none known CT: none known TF: has received financial paymentfor speaker's fees (Mitsubishi Tanabe Pharma Corporation), clinicaltrial consultancy (Mitsubishi Tanabe Pharma Corporation, Sony Electronics), scientific advisory board (Kyoto University Original), grant (Shionogi) and declares intellectual properties and patent-pending (2020-548587) for smartphone CBT apps (Mitsubishi Tanabe Pharma Corporation). NW: his institution has received research funds from the Japanese Ministry of Health Labor and Welfare and the Japanese Ministry of Education, Science, and Technology.He has also received royalties from Sogensha and Akatsuki for writing a book and developing soNware about interventions for insomnia. This review is completely independent from the intention of these grants.

 

Inclusion criteria SR:

  • Randomised controlled trials (RCTs), including cluster randomised controlled trials, cross-over trials, and quasi-RCTs, (RCTs in which participants are allocated based on data such as date of birth, date of recruitment, or medical record number).
  • All adult participants (≥18 years old) with any clinical characteristics, in any setting, who required a peripheral intravenous line, irrespective of the difficulty of cannulation.

 

Exclusion criteria

  • Central lines, intraosseous lines, and peripherally inserted central lines;
  • children because the effect of ultrasound guidance would be different for them, due to smaller veins and extremities, and a possible lack of cooperation.

 

16 studies included

 

Important patient characteristics at baseline:

 

N

A: 35

B: 122

C: 114

D: 60

E: 90

F: 60
G: 60

H: 192

I: 401

J: 596

K: 60

L: 18

M: 47

N: 300

O: 59

P: 53

 

Groups comparable at baseline?

Yes.

Describe intervention:

 

A: Ultrasound guidance.

B: Ultrasound guidance.

C: Ultrasound guidance.

D: Ultrasound guidance.

E: Ultrasound guidance.

F: Ultrasound guidance.
G: Ultrasound guidance.

H: Ultrasound guidance.

I: Ultrasound guidance.

J: Ultrasound guidance.

K: Ultrasound guidance.

L: Ultrasound guidance.

M: Ultrasound guidance.

N: Ultrasound guidance.

O: Ultrasound guidance.

P: Ultrasound guidance.

 

Describe  control:

 

A: Landmark technique.

B: Landmark technique.

C: Landmark technique.

D: Landmark technique.

E: Landmark technique.

F: Landmark technique.
G: Landmark technique.

H: Landmark technique.

I: Landmark technique.

J: Landmark technique.

K: Landmark technique.

L: Landmark technique.

M: Landmark technique.

N: Landmark technique.

O: Landmark technique.

P: Landmark technique.

 

End-point of follow-up:

 

A: No information.

B: No information.

C: No information.

D: No information.

E: No information.

F: No information.
G: No information.

H: No information.

I: No information.

J: No information.

K: No information.

L: No information.

M: No information.

N: No information.

O: No information.

P: No information.

 

For how many participants were no complete outcome data available?

(intervention/control)

A: None.

B: None.

C: None.

D: None.

E: None.

F: None.
G: None.

H: None.

I: None.

J: None.

K: None.

L: None.

M: None.

N: None.

O: None.

P: None.

 

 

 

Results

See original publication.

 

 

 

 

 

 

Author’s conclusion

There is very low- and low-certainty evidence that, compared to the landmark method, ultrasound guidance may benefit difficult participants for increased first-pass and overall success of cannulation, with no difference detected in pain. There is moderate- and low certainty evidence that, compared to the landmark method, ultrasound guidance may benefit moderately difficult participants due to a small increased first-pass success of cannulation with no difference detected in pain. There is moderate- and high-certainty evidence that, compared to the landmark method, ultrasound guidance does not benefit easy participants: ultrasound guidance decreased the first-pass success of cannulation with no difference detected in overall success of cannulation and increased pain.

Systematic review(s) PICO 3

Not applicable.

 

Randomized controlled trial(s) PICO 1

Study reference

Study characteristics

Patient characteristics 2

Intervention (I)

Comparison / control (C) 3

 

Follow-up

Outcome measures and effect size 4

Comments

Airapetian (2013)

Type of study:

Randomized controlled trial.

 

Setting and country:

Eight-bed medical ICU of a university hospital.

 

Funding and conflicts of interest:

Authors have no conflict of interest.

No information regarding funding.

 

Inclusion criteria:

  • Need for jugular or femoral central cannula placement, as determined by the attending physician caring for the patient.

 

Exclusion criteria:

  • The decision to place a subclavian catheter.

 

N total at baseline:

Jugular vein

I: N = 21

C: N = 21

 

Femoral vein

I: N = 15

C: N = 10

 

Important prognostic factors2:

age ± SD:

I: 63 (15) years.

C: 67 (16) years.

 

Sex:

I: Ratio 2.6

C: Ratio 1.9

 

BMI:

I: 25 (6) kg/m2

C: 28 (6) kg/m2

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound-guided technique.

 

Describe control (treatment/procedure/test):

 

Landmark technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate

Jugular vein

I: 21/21 (100%)

C: 21/28 (75%)

 

Femoral vein

I: 15/15 (100%)

C: 7/10 (70%)

 

All sites

I: 36/36 (100%)

C: 28/38 (74.0%)

 

Complications

Jugular vein

I: 0/21 (0%)

C: 7/28 (25.0%)

 

Femoral vein

I: 0/15 (0%)

C: 2/10 (20.0%)

 

Number of attempts

I: 1 times

C: 3 (1) times

 

Access time

I: 4 (2) minutes

C: 8 (7) minutes

 

Catheter colonization

I: 9/36 (25.0%)

C: 7/28 (18.0%)

Author’s conclusion:

Ultrasound-guided cannulation of the internal jugular or femoral vein by inexperienced residents appears to be more reliable than the LM or UM methods and was associated with a lower mechanical complication rate among ICU patients.

Benali (2022)

Type of study:

Randomized controlled trial.

 

Setting and country:

No information.

 

Funding and conflicts of interest:

No information.

 

Inclusion criteria:

  • Patients 18 years or older requiring elective central venous catheterization after obtaining a written informed consent from the patient or trusted person.

 

Exclusion criteria:

  • Vein thrombosis;
  • Major blood the coagulation disorders;
  • Cannulation site infection.

 

N total at baseline:

Subclavian vein

Intervention: N = 35

Control: N = 35

 

Important prognostic factors2:

age ± SD:

I: 48 (20) years.

C: 44 (18) years.

 

BMI >30

I: 7/35 (20%)

C: 4/35 (11.4%)

 

BMI <30

I: 28/35 (80.0%)

C: 31/35 (88.6%)

 

Groups comparable at baseline?

Describe intervention (treatment/procedure/test):

 

Ultrasound guidance

 

Describe control (treatment/procedure/test):

 

Landmark technique

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

 

Success rate (overall)

I: 35/35 (100%)

C: 30/35 (85.7%)

 

Success rate (obesitas)

I: 7/7 (100%)

C: 1/4  (25.0%)

 

First attempt success rate (overall)

I: 29/35 (82.9%)

C: 14/35 (40.0%)

 

Number of attempts (overall)

I: 1 (range 1 to 1)

C: 2 (range 1 to 4)

 

Complications (overall)

Arterial puncture

I: 0/35 (0%)

C: 5/35 (14.3%)

 

Hematoma

I: 0/35 (0%)

C: 9/35 (25.7%)

 

Pneumothorax

I: 0/35 (0%)

C: 2/35 (5.7%)

 

Malposition

I: 2/35 (5.7%)

C: 1/35 (2.9%)

Author’s conclusion:

According to our study, US guidance for SCV catheterization seems to be an interesting alternative to anatomical landmarks approaches.

Dolu (2015)

Type of study:

Randomized controlled trial.

 

Setting and country:

Medical faculty of Gaziantep University.

 

Funding and conflicts of interest:

The authors declare that they have no conflict of interest.

 

Inclusion criteria:

  • Patients who required elective cardiovascular surgery.

 

Exclusion criteria:

  • No information.

 

N total at baseline:

Jugularis vein

Intervention: N = 50

Control: N = 50

 

Important prognostic factors2:

age ± SD:

I: 53.6 (5.8) years.

C: 53.2 (9.10) years.

 

BMI:

I: 25.7 (2.6) kg/m2

C: 26.6 (3.7) kg/m2

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound guidance.

 

 

Describe control (treatment/procedure/test):

 

Landmark technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Number of needles passes

I: 1.1 (0.5) needles

C: 2.2 (1.6) needles

 

Duration of procedure in seconds

I: 109.4 (30.4) seconds

C: 165.9 (91.5) seconds

 

Complications

Arterial puncture

I: 0/50 (0%)

C: 4/50 (8.0%)

 

Hematoma

I:(1/50 (2.0%)

C: 1/50 (2.0%)

 

Total

I: 1/50 (2.0%)

C: 5/50 (10.0%)

Author’s conclusion:

The findings of this study indicate that internal jugular vein catheterization guided by real-time ultrasound results in a lower access time and a lower rate of attempts.

Ethesham (2020)

Type of study:

Randomized controlled trial.

 

Setting and country:

Poona Hospital and Research Centre, Pune, India

 

Funding and conflicts of interest:

None declared.

 

Inclusion criteria:

  • Patients who underwent major surgeries under general anaesthesia requiring central venous pressure monitoring, rapid infusion of fluids for major surgery, drug administration, and inadequate peripheral access.

 

Exclusion criteria:

  • Patients who had infection at the local site, bleeding diathesis/ coagulopathy.

 

N total at baseline:

Internal jugular vein

Intervention: N = 45

Control: N = 45

 

Important prognostic factors2:

age ± SD:

I: 47.3 (13.6) years.

C: 46.4 (14.2) years.

 

Sex:

I: 22/45 (48.9%) M

C: 28/45 (62.2%) M

 

BMI around 22 kg/m2 in both groups.

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound-guidance.

Describe control (treatment/procedure/test):

 

Landmark-based technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate

I: 45/45 (100%)

C: 43/45 (95.6%)

 

Complications

Nil

I: 45/45 (100%)

C: 33/45 (73.3%)

 

Hematoma

I: 0/45 (0%)

C: 8/45 (17.8%)

 

Carotid artery puncture

I: 0/45 (0%)

C: 4/45 (8.9%)

 

Mean time required for the procedure in minutes

I: 4.2 (0.4) minutes

C: 4.7 (0.8) minutes

Author’s conclusion:

USG guided cannulation of IJV decreases access time, reduces attempts, and complication rates. USG guided technique may be preferred for cannulation of IJV.

Faithi (2016)

Type of study:

Randomized controlled trial.

 

Setting and country:

No information.

 

Funding and conflicts of interest:

This study was supported by the research deputy of Mashhad at the University of Medical Sciences

 

Inclusion criteria:

  • No information.

 

Exclusion criteria:

  • Patients who had a right jugular vein cannulation for any reason, such as those who required hemodialysis

 

N total at baseline:

Internal jugular vein

Intervention: N = 170

Control: N = 151

 

Important prognostic factors2:

age ± SD:

I: 64.45 (11.29) years.

C: 62.15 (9.76) years.

 

Sex:

I: 103/170 M

C: 102/151 M

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound guidance.

 

Describe control (treatment/procedure/test):

 

Landmark-based technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate

First attempt

I: 156/170 (91.8%)

C: 140/151 (92.7%)

 

Second attempt

I: 8/170 (4.2%)

C: 6/151 (4.0%)

 

Third attempt

I: 6/170 (3.6%)

C: 5/151 (3.3%)

 

Time required for cannulation

I: 46.05 (12.7) seconds

C: 45.56 (10.9) seconds

Author’s conclusion:

In our conditions, the use of an anatomical landmark-guided procedure was the preferred treatment method due to limited resources and a lack of adequate training.

Nazari (2015)

Type of study:

Randomized controlled trial.

 

Setting and country:

No information.

 

Funding and conflicts of interest:

No information.

Inclusion criteria:

  • All patients who have had indications for central venous cannulation

 

Exclusion criteria:

  • Patients with previous CVC within 15 days, anatomical deformity (such as neck surgery, malignancy and burns on the site), having emergency conditions and bleeding disorders.

 

N total at baseline:

Internal jugular vein

Intervention: N = 168

Control: N = 168

 

Important prognostic factors2:

age ± SD:

I: 54.8 (7.6) years.

C: 49.9 (10.6) years.

 

Sex:

I: 90/168 (53.5%) M

C: 87/168 (51.7%) M

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound guidance.

 

Describe control (treatment/procedure/test):

 

Landmark-based technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate

From skin prep to successful aspiration (in seconds)

I: 132.52 (15.1) seconds.

C: 169.2 (16.21)

 

Number of patients required more than one attempt

I: 22/168 (13.09%)

C: 75/168 (44.6%)

 

Successful cannulation

Mean number of attempts

I: 1.4 (0.42)

C: 1.98 (0.61)

Author’s conclusion:

The results of our study showed that USG approach took lesser time, required lesser attempts, and had lower incidence of complications for cannulation of the internal jugular vein.

Oh (2014)

Type of study:

Randomized controlled trial.

 

Setting and country:

Seoul National University

Bundang Hospital.

 

Funding and conflicts of interest:

The authors declare that they have no competing interests

 

Inclusion criteria:

  • Patients between the age of 18 and 75 years (ASA physical status I–III), who required subclavian venous catheterization.

 

Exclusion criteria:

  • Patients with chest deformities or significant coagulopathy.

 

N total at baseline:

Subclavian

Intervention: N = 30

Control: N = 30

 

Important prognostic factors2:

age ± SD:

I: 51 (14) years.

C: 50 (16) years.

 

Sex:

I: 15/30 (50%) M

C: 16/30 (53.3%) M

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound guidance.

 

Describe control (treatment/procedure/test):

 

Landmark-based technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate

I: 26/30 (86.7%)

C: 16/30 (53.3%)

 

Complications

I: 0/30 (0%)

C: 0/30 (0%)

Author’s conclusion:

The proper placement of guidewire was less influenced by the direction of the guidewire J-tip with ultrasound-guided subclavian venous cannulation than with the landmark approach.

Palkhiwala (2020)

Type of study:

Randomized controlled trial.

 

Setting and country:

No information.

 

Funding and conflicts of interest:

No information.

 

Inclusion criteria:

  • Adult patients with ASA Grade II and II posted for major surgeries;
  • Patients willing to enrol in the study;
  • Patients aged 18 years or older.

 

Exclusion criteria:

  • Patients who do not give consent;
  • Skin inflammation at insertion site;
  • Altered coagulation profile (platelet count <50.000 per cu mm, INR > 1.5).;
  • Patients with known bleeding disorders;
  • Prior catheterization;
  • Subcutaneous emphysema;
  • Patients undergoing radiation therapy.

 

N total at baseline:

Jugularis

Intervention: N = 30

Control: N = 30

 

Important prognostic factors2:

age ± SD:

I: 53.1 (15.05) years.

C: 50.1 (15.70) years.

 

Sex:

I: 20/30 (66.7%) M

C: 22/30 (73.3%) M

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound guidance.

 

Describe control (treatment/procedure/test):

 

Landmark-based technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate

First attempt

I: 28/30 (93.33%)

C: 20.30 (66.67%)

 

Second attempt

I: 2/30 (6.67%)

C: 7/30 (23.34%)

 

Third attempt

I: 0/30 (0%)

C: 3/30 (10.0%)

 

Complications

Total

I: 2/30 (6.67%)

C: 9/30 (30.0%)

 

Hematoma

I: 1/30 (3.33%)

C: 2/30 (6.67%)

 

Carotid artery puncture

I: 0/30 (0%)

C: 3/30 (10.0%)

 

Pneumothorax

I: 0/30 (0%)

C: 1/30 (3.3%)

 

Double wall puncture

I: 1/30 (3.3%)

C: 3/30 (10.0%)

 

Number of attempts

I: 1.06 (0.24)

C: 1.43 (0.66)

 

Access time

I: 9.63 (1.85) seconds

C: 19.30 (8.85) seconds

Author’s conclusion:

We conclude that use of ultrasound makes cannulation of the IJV a much safer technique, especially in high-risk patients, and leaves almost none to minimal chances of any complications. With experience, expertise and under real-time vision, the contra-indications to a central line insertion are almost nullified

Rando (2014)

Type of study:

Randomized controlled trial.

 

Setting and country:

Intensive care unit and operating rooms of the military hospital in motevideo, Uruguay.

 

Funding and conflicts of interest:

None declared.

 

Inclusion criteria:

  • Critically ill patients or those that required surgery and a CVL.

 

Exclusion criteria:

  • Patients under 18 years old;
  • Conscious but non-collaborative patients.

 

N total at baseline:

Jugular vein

Intervention: N = 123

Control: N = 134

 

Important prognostic factors2:

age ± SD:

Ranging from a mean of 55 to 62 years.

 

BMI:

Ranging from 27.5 to 27.8 kg/m2

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound guidance.

 

Describe control (treatment/procedure/test):

 

Landmark technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate (overall)

I: 112/123 (91.0%)

C: 105/134 (78.0%)

 

Success rate (difficult neck)

I: 42/46 (93.0%)

C: 24/37 (65.0%)

 

Complications (overall)

I: 10/123 (8.1%)

C: 20/134 (15.0%)

 

Multiple puncture (overall)

I: 48/123 (39.0%)

C: 54/134 (40.0%)

 

 

Author’s conclusion:

Ultrasound reduces the incidence of complications when placement is performed by inexperienced operators. Centers with residents should emphasize the necessity of ultrasound for central line catheterization. Training in ultrasound might be of paramount importance in the effectiveness of the technique.

Riaz (2015)

Type of study:

Randomized controlled trial.

 

Setting and country:

Anaesthesia department.

 

Funding and conflicts of interest:

No information.

 

Inclusion criteria:

  • Adult patients who required intravenous jugular vein catheterization.

 

Exclusion criteria:

  • Patients with local or systemic infection, known vascular abnormalities, untreated coagulopathy

 

N total at baseline:

Jugularis

Intervention: N = 100

Control: N = 100

 

Important prognostic factors2:

age ± SD:

I: 44.25 (14.43) years.

C: 48.59 (14.57) years.

 

Sex:

I: 74/100 (74.0%) M

C: 81/100 (81.0%) M

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound guidance.

 

Describe control (treatment/procedure/test):

 

Landmark-based technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate

First attempt

I: 99/100 (99.0%)

C: 89/100 (89.0%)

 

Second attempt

I: 1/100 (1.0%)

C: 7/100 (7.0%)

 

Complications

Carotid artery puncture

I: 1/100 (1.0%)

C: 9/100 (9.0%)

 

Irritation of brachial plexus

I: 0/100 (0%)

C: 6/100 (6.0%)

 

Hematoma

I: 0/100 (0%)

C: 7/100 (07.0%)

 

Hemothorax

I: 0/100 (0%)

C: 0/100 (0%)

 

Pneumothorax

I: 0/100 (0%)

C: 0/100 (0%)

 

Access time (in seconds)

I: 34.95 (11.47) seconds

C: 146.59 (40.20) seconds

Author’s conclusion:

Access time, failure rate and procedure related complications are reduced when real-time ultrasonography is used to cannulate internal Jugular vein.

Srinivasan (2017)

Type of study:

Randomized controlled trial.

 

Setting and country:

Adult Gastroenterology and Liver Intensive Care Unit.

 

Funding and conflicts of interest:

There are no conflicts of interest.

No funding.

 

Inclusion criteria:

  • Both surgical and medical gastroenterology patients in whom central venous lines were indicated as a part of their medical management.

 

Exclusion criteria:

  • Patient/relatives refusal for central venous line placement, choice of alternate site for central venous cannulation (besides IJV), presence of thrombus within the jugular vein and infection at chosen site of catheter insertion.

 

N total at baseline:

Jugularis

Intervention: N = 90

Control: N = 80

 

Important prognostic factors2:

age ± SD:

I: 52.1 (14.2)

C: 48.6 (15.7)

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound guidance.

 

Describe control (treatment/procedure/test):

 

Landmark-based technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate

First attempt

I: 90//90 (100.0%)

C: 60/80 (75.0%)

 

Second attempt

I: 0/90 (0%)

C: 18/80 (22.5%)

 

Third attempt

I: 0/90 (0%)

C: 2/80 (2.5%)

 

Complications

Posterior wall puncture of internal jugular vein

I: 19/90 (21.0%)

C: 37/80 (46.0%)

 

Inadvertent arterial puncture

I: 5/90 (5.5%)

C: 8/80 (10.0%)

 

Hematoma

I: 1/90 (1.1%)

C: 11/80 (13.8%)

 

Pneumothorax

I: 0/90 (0%)

C: 1/80 (1.3%)

 

Author’s conclusion:

Real-time ultrasound-guided IJV cannulation significantly reduces but does not wholly eliminate the incidence of posterior venous wall penetrations. It also significantly reduces the incidence of inadvertent arterial punctures and number of attempts for successful cannulation.

Subramony (2022)

Type of study:

Randomized controlled trial.

 

Setting and country:

Urban tertiary care

teaching hospital.

 

Funding and conflicts of interest:
No information.

 

 

Inclusion criteria:

  • Patients who required assessment of administration of vasoactive drugs or large volume fluid resuscitation or patients in which there was failure to obtain the necessary peripheral venous access.

 

Exclusion criteria:

  • Patients with a high bleeding risk. This was defined by an international normalized ratio >2.5 or platelet count of

 

N total at baseline:

Subclavian vein

Intervention: N = 44

Control: N = 41

 

Important prognostic factors2:

age ± SD:

No information

 

Sex:

No information

 

Groups comparable at baseline?

No information.

Describe intervention (treatment/procedure/test):

 

Ultrasound-guidance.

 

Describe control (treatment/procedure/test):

 

Landmark technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate

I: 35/44 (79.5%)

C: 24/41 (58.5%)

 

 

Author’s conclusion:

Ultrasound-guided subclavian vein catheterization was found to be associated with a higher overall success rate compared with the landmark method with no significant difference with respect to complication rate in an ED setting.

Vinayagamurugan (2021)

Type of study:

Randomized cross-over clinical trial.

 

Setting and country:

Tertiary care University hospital.

 

Funding and conflicts of interest:

None.

 

Inclusion criteria:

  • Patients aged than 18 years of age undergoing elective or emergency surgery under general anesthesia.

 

Exclusion criteria:

  • Patients who had distorted neck anatomy, previous neck surgeries, neck mass, torticollis, neck contracture and previous history of long term IJV catheterization.

 

N total at baseline:

Jugularis

Intervention: N = 94

Control: N = 94

 

Important prognostic factors2:

age ± SD:

I: 45.9 (14.32) years.

C: 45.01 (15.35) years.

 

Sex:

I: 54/94/ (57.44%) M

C: 61/94 (64.89%) M

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound guidance.

 

Describe control (treatment/procedure/test):

 

Landmark-based technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate (overall)

I: 94/94 (100%)

C: 94/94 (100%)

 

Success rate (first attempt)

I: 84/94 (89.34%)

C: 75/94 (79.78%)

 

Complications

Total

I: 4/94 (4.25%)

C: 12/94 (12.76%)

 

Carotid artery puncture

I: 2/94 (2.12%)

C: 2/94 (2.12%)

 

Hematoma

I: 2/94 (2.12%)

C: 4/94 (4.25%)

 

Mechanical complications (pneumothorax, hemothorax, hemomediastinum, cardic tamponade, nerve injury, catheter malposition)

I: 0/94 (0%)

C: 0/94 (0%)

 

Cannulation time

I: 44.27 (5.28) seconds

C: 58.11 (6.6) seconds.

Author’s conclusion:

In patients with non-distorted neck anatomy and a visible EJV, IJV catheterization using the EJV-based LM approach and standard US-guided technique yielded similar first attempt and overall success rates. Cannulation time was longer and complications occurred more frequently in the EJV-based LM compared to the standard US-guided technique.

Wang (2020)

Type of study:

Pilot RCT.

 

Setting and country:

ICU hospital.

 

Funding and conflicts of interest:

This study was funded by the grants from the Science and Technology Bureau of Jiaxing city, Zhejiang, China (No.2017AY33034 to J.M. Cai; and No.2020AD30082 to Q.Y. Wang).

 

Inclusion criteria:

  • : ICU inpatient, age > 18 years, and required subclavian vein puncture.

 

Exclusion criteria:

  • Severe coagulation disorder (i.e., international normalized ratio [INR] > 3.5 or disseminated intravascular coagulation with active bleeding), platelet count (PLT) < 20,000/ mL, bilateral pneumothorax, cardiopulmonary resuscitation, or emergency subclavian vein puncture.

 

N total at baseline:

Subclavian

Intervention: N = 96

Control: N = 98

 

Important prognostic factors2:

age ± SD:

I: 21.6 (8.7)

C: 22.5 (8.3)

 

Sex:

I: 23/96 (24.0%) F

C: 34/98 (34.7%) F

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound guidance.

 

Describe control (treatment/procedure/test):

 

Landmark-based technique.

Length of follow-up:

 

Loss-to-follow-up:

 

 

Success rate

I: 88/96 (91.7%)

C: 76/98 (77.6%)

 

First attempt success

I: 57/96 (59.4%)

C: 48/98 (49.0%)

 

Complications

Total

I: 7/96 (7.3%)

C: 20/98 (20.4%)

 

Mispuncture of artery

I: 2/96 (2.1%)

C: 14/98 (14.3%)

 

Hematoma

I: 0/96 (0%)

C: 1/98 (1.0%)

 

Pneumothorax

I: 0/96 (0%)

C: 2/98 (2.0%)

 

Number of punctures

I: 1.6 (1.0)

C: 1.5 (0.7)

 

Puncture time

I: 50 (47) seconds

C: 62 (53) seconds

 

Author’s conclusion:

Static ultrasoundguided subclavian vein puncture is superior to the traditional

landmark-guided approach for critically ill patients in the

ICU. It is suggested that static ultrasound-guided puncture

techniques should be considered for subclavian vein puncture

in the ICU.

Zhang (2023)

Type of study:

Randomized controlled trial.

 

Setting and country:

No information.

 

Funding and conflicts of interest:

The authors declare that they have no conflicts of interest.

 

Inclusion criteria:

  • No information.

 

Exclusion criteria:

  • No information.

 

N total at baseline:

Subclavian vein

Intervention: N = 30

Control: N = 30

 

Important prognostic factors2:

age ± SD:

I:  <60 N = 4 / >60 N = 26

C: <60 N =5 / >60 N = 25

 

Sex:

I: 27/30 M

C: 22/30 M

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound-guidance.

 

Describe control (treatment/procedure/test):

 

Landmark technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

 

Success rate

First attempt

I: 24/30

C: 20/30

 

Total

I: 30/30

C: 30/30

 

Complications

Pneumothorax

I: 1/30

C: 5/30

 

Hematoncus

I: 2/30

C: 6/30

 

Intubation time

I: 6.3333 minutes

C: 11.3667 minutes

Author’s conclusion:

Te improved ultrasound-guided subclavian vein catheterization technique can greatly reduce the catheterization time and improve the success rate of puncture and catheterization. It can also reduce the occurrence of complications and damage to adjacent tissues. Te operation is simple, fast, and easy to master, and it has a high popularization clinical value.

Randomized controlled trial(s) PICO 2

Study reference

Study characteristics

Patient characteristics 2

Intervention (I)

Comparison / control (C) 3

 

Follow-up

Outcome measures and effect size 4

Comments

Yalcinli (2022)

Type of study:

Randomized controlled trial.

 

Setting and country:

An emergency

department of an academic tertiary care hospital

 

Funding and conflicts of interest:

No conflicts of

interest declared. This article received no specific grant from any funding agency.

 

Inclusion criteria:

  • Patients describing DVA history (>two trial histories during vascular access on a previous visit), with no visible or palpable veins on the upper extremity, and who were assessed to have a difficult procedure by the senior nurse (according to classification: easy-moderate-difficult)

 

Exclusion criteria:

  • Patients who did not provide
  • consent, pregnant, <18 years of age, and urgent critical intervention needs were excluded

 

N total at baseline:

Intervention: N = 90

Control: N = 90

 

Important prognostic factors2:

age (median. IQR):

I: 64 (49 to 77)

C: 68.5 (51 to 76)

 

Sex:

I: 39/90 male

C: 34/90 male

 

Groups comparable at baseline?

Yes.

Describe intervention (treatment/procedure/test):

 

Ultrasound-guided placement.

 

Describe control (treatment/procedure/test):

 

Landmark-based technique.

Length of follow-up:

No information.

 

Loss-to-follow-up:

None.

First attempt success

I: 71/90 (78.9%)

C: 56/90 (62.2%)

 

Catheter-related interventions

I: 17/90 (18.9%)

C: 17/90 (18.9%)

 

Duration of the procedure (Median, IQR, 95% CI)

I: 107 (IQR 69 to 228, 95% CI 140 to 209) seconds

C: 72 (IQR 47 to 134, 95% 86 to 128) seconds

 

Number of total attempts (Median, IQR, 95% CI)

I: 1.0 (IQR 1.0 to 1.0, 1.25 to 1.64)

C: 1.0 (IQR 1.0 to 2.0, 95% CI 1.35 to 1.74)

Author’s conclusion:

It was found that USG increases the success of the first attempt compared with

the standard method and NIR in patients with DVA.

Risk of bias tabel

Study reference

 

(first author, publication year)

Was the allocation sequence adequately generated?

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?

 

Were patients/healthcare providers/data collectors/assessors/data analysts blinded?

 

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure

 

 

 

 

 

 

LOW

Some concerns

HIGH

 

 

PICO 1: Central venous catheters

 

Airapetian (2013)

Definitely yes.

 

Reason:  patients were randomly assigned to the three groups

No information.

 

Reason: -

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

Probably yes.

 

Reason: No other bias reported.

 Low.

Benali (2022)

Definitely yes.

 

Reason:  Patients were randomly divided according to computer

generated randomized table into two groups.

 

Definitely yes.

 

Reason: Computer generated.

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

 

Definitely yes.

 

Reason: All predefined outcomes were reported.

Probably yes.

 

Reason: No other bias reported. 

 Low.

Dolu (2015)

Definitely yes.

 

Reason:  patients were randomly assigned to the groups.

 

No information.

 

Reason: -

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported. 

 Low.

Ethesham (2020)

Definitely yes.

 

Reason: Randomly divided into two groups.

No information.

 

Reason: -

Partly yes.

 

Reason: The patients were blind (single blind study) to the study.

 

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Faithi (2016)

Definitely yes.

 

Reason: patients were randomly assigned to either the control (anatomical landmark-guided) or experimental (ultrasound-guided) groups

 

Probably yes.

 

Reason: based upon the order of their entrance to the operating room.

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Nazari (2015)

Definitely yes.

 

Reason: From patients 340 cases were selected based on inclusion and exclusion criteria, 4 of them not participate to the study and other 336 cases allocated with a simple random sampling method in 2 groups of intervention and control (168 cases in each groups).

 

No information.

 

Reason: -

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Oh (2014)

Definitely yes.

 

Reason: Patients were randomly divided into a landmark group (n = 30) or an ultrasound group (n = 30).

 

No information.

 

Reason: -

Definitely no.

 

Reason: this in- vestigation was not-blinded because the catheterization could not be disguised; therefore, there was a possibility of a bias.

 

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Palkhiwala (2020)

Definitely yes.

 

Reason: Randomly divided into two groups.

No information.

 

Reason: -

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Rando (2014)

Definitely yes.

 

Reason:  Randomization was performed through a computer random number generator

Definitely yes.

 

Reason: placing the results in sheets inside closed enve- lopes, which were opened right before CVL placement.

 

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Riaz (2015)

Definitely yes.

 

Reason: patients who required internal jugular vein cannulation were randomly assigned.

 

No information.

 

Reason: -

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Srinivasan (2017)

Definitely yes.

 

Reason: Randomly divided into two groups.

Definitely yes.

 

Reason: The allocation was concealed in an opaque-sealed envelope. The envelope was opened just before the central line (IJV line) placement

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Subramony (2022)

Definitely yes.

 

Reason: Patients were randomized according to an odd or even numbering system found on the inside of the data packet. Odd numbers were randomized to the traditional method while even numbers were assigned to the ultrasoundguided group.

 

No information.

 

Reason: -

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Vinayagamurugan (2021)

Definitely yes.

 

Reason: Randomly divided into two groups.

 

Reason:

Partly yes.

 

Reason: Resident physician who performed the procedures were not blinded to study. However, patients and postoperative assessors of mechanical complications were blinded to study.

 

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Wang (2020)

Definitely yes.

 

Reason: Randomly divided into two groups.

Definitely yes.

 

Reason: The allocation sequence, which was based on a random number table, was prepared by a third-party biostatistician in sequentially numbered sealed opaque envelopes.

 

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Zhang (2023)

Definitely yes.

 

Reason: Randomly divided into two groups.

No information.

 

Reason: -

No information.

 

Reason: -

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

 

PICO 2: Peripheral intravenous catheters

 

Yalcinli (2022)

 

Reason: 

 

Reason:

 

Reason:

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

 

PICO 3: Peripherally inserted central catheters

 

Wang (2016)

 

Reason: 

 

Reason:

 

Reason:

No loss to follow-up reported.

 

Reason: -

Definitely yes.

 

Reason: All predefined outcomes were reported.

 

Probably yes.

 

Reason: No other bias reported.

 Low.

Exclusie tabel

Author and year

Reason for exclusion

Anderssen (2022)

The included RCTs in this systematic review are already included in a more recent published systematic review which is included in this guideline.

Berlanga-Macis (2022)

Wrong study design.

Hansel (2023)

Wrong study population.

McCarthy (2016)

The RCT is already included in the systematic review of Tada (2022) which is included in this guideline.

Misiołek (2012)

The full-text version of this study is not available.

Oleti (2019)

Wrong study population.

Poulsen (2023)

The studies regarding adults are already included in the systematic review of Tada (2022). Poulsen (2023) includes three more studies about children, but children are beyond the scope of this review.

Sazdov (2017)

Study did not report results for the jugular vein, subclavian vein, and femoral vein separately.

Tran (2021)

The included RCTs in this systematic review are already included in a more recent published systematic review which is included in this guideline.

Wang (2016)

Wrong comparison for PICO 3.

Xia (2014)

The full-text version of this study is not available.

Xu (2013)

The full-text version of this study is not available.

Beoordelingsdatum en geldigheid

Laatst beoordeeld  : 25-06-2025

Nog in afwachting autorisatie van de volgende partijen:

  • Vereniging voor Hygiëne en Infectiepreventie in de Gezondheidszorg
  • Patiëntenfederatie Nederland

Initiatief en autorisatie

Initiatief:
  • Nederlandse Vereniging voor Heelkunde
Geautoriseerd door:
  • Nederlandse Internisten Vereniging
  • Nederlandse Vereniging voor Anesthesiologie
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Medische Microbiologie
  • Nederlandse Vereniging voor Radiologie
  • Samenwerkingsverband Richtlijnen Infectiepreventie

Algemene gegevens

De ontwikkeling/herziening van deze richtlijnmodule werd ondersteund door het Kennisinstituut van de Federatie Medisch Specialisten (www.demedischspecialist.nl/kennisinstituut) en werd gefinancierd uit de Stichting Kwaliteitsgelden Medisch Specialisten (SKMS). De financier heeft geen enkele invloed gehad op de inhoud van de richtlijnmodule.

Samenstelling werkgroep

Voor het ontwikkelen van de richtlijnmodule is in 2022 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen (zie hiervoor de Samenstelling van de werkgroep) die betrokken zijn bij de zorg rondom vaattoegangswegchirurgie.

 

Werkgroep

  • dr. C.G. (Niels) Vos (voorzitter), Nederlandse Vereniging voor Heelkunde
  • dr. M.E. (Marianne) Sitsen (vice-voorzitter), Nederlandse Vereniging voor Anesthesiologie
  • dr. M.J. (Marijke) Molegraaf, Nederlandse Vereniging voor Heelkunde
  • dr. M.G.J. (Maarten) Snoeijs, Nederlandse Vereniging voor Heelkunde
  • dr. M. (Mahir) Üslü, Nederlandse Vereniging voor Anesthesiologie
  • dr. M. (Michelle) Gompelman, Nederlandse Internisten Vereniging
  • dr. E.R. (Eric) van der Vorm, Nederlandse Vereniging voor Medische Microbiologie / Samenwerkingsverband Richtlijnen Infectiepreventie
  • drs. Ir. P.A.A. (Pum) Le Haen, Nederlandse Vereniging voor Radiologie

 Klankbordgroep

  • dr. H. (Hanneke) Buter, Nederlandse Vereniging voor Intensive Care
  • Werkgroep SRI-richtlijn Veneuze en arteriële katheters

Met ondersteuning van

  • dr. M.S. (Matthijs) Ruiter, senior adviseur, Kennisinstituut van de Federatie Medisch Specialisten
  • M. (Mitchel) Griekspoor, MSc, adviseur, Kennisinstituut van de Federatie Medisch Specialisten

Belangenverklaringen

De Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengeling is gevolgd. Alle werkgroepleden hebben schriftelijk verklaard of zij in de laatste drie jaar directe financiële belangen (betrekking bij een commercieel bedrijf, persoonlijke financiële belangen, onderzoeksfinanciering) of indirecte belangen (persoonlijke relaties, reputatiemanagement) hebben gehad. Gedurende de ontwikkeling of herziening van een module worden wijzigingen in belangen aan de voorzitter doorgegeven. De belangenverklaring wordt opnieuw bevestigd tijdens de commentaarfase.

 

Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten.

Werkgroeplid

Hoofdfunctie

Project Tekstveld

Nevenwerkzaamheden

Persoonlijke Financiële belangen

Persoonlijke relaties

Extern gefinancierd onderzoek

Intell. Belangen en reputatie

Overige belangen

Ondernomen actie

Niels Vos (vz.)

Vaatchirurg

Richtlijn Centraal Veneuze Toegang

Voorzitter huidige richtlijncommissie.

Geen.

Geen.

1. Studie naar functioneren van Artivion (Jotec) EVAR prothese. Gefinancierd door Artivion. Multicenter, ik ben lokale (martini ziekenhuis) hoofdonderzoeker. Het ziekenhuis krijgt een onkosten vergoeding van een paar 100 euro. Persoonlijk krijg ik er niets voor. Het is een reguliere verkrijgbare stent waar de leverancier wilde kijken hoe deze presteert (technisch/klinisch en QoL).

 

2.Door ZonMW gefinancierde multicenter trial naar antistolling na pta (CLEARPATH trial, RCT, clopidogrel / placebo vs clopidogrel / ascal na dotter). Hier is een onkostenvergoeding per patiënt voor die naar het ziekenhuis (wetenschappelijk instituut) gaat. Ik ben ook hier lokale hoofdonderzoeker.

 

Geen.

Geen.

Geen restricties. Extern gefinancierd onderzoek valt buiten bestek van de richtlijn.

Eric van der Vorm

Arts-microbioloog

Richtlijn Centraal Veneuze Toegang

Geen.

Geen.

Geen.

Geen.

Geen.

Geen.

Geen restricties.

Maarten Snoeijs

Vaatchirurg

Centraal Veneuze Toegang & Cluster expertisegroep Arteriële en Veneuze Pathologie.

Geen.

Geen.

Geen.

1. OASIS Zorgevaluatie (Zorgevaluatie Nederland)

2. FLOW Zorgevaluatie (ZonMw)

3. Personalised hemodynamic modeling of arteriovenous grafts for prediction of vascular access stenosis and thrombosis (Vascular Access Society research grant)

4. ShuntSimulationStudy (Nierstichting).

 

Leider expertisecentrum met topreferente zorgfunctie voor vaattoegangchirurgie in MUMC+

Geen.

Geen restricties. Extern gefinancierd onderzoek valt buiten bestek van de richtlijn.

Mahir Üslü

Anesthesioloog

Richtlijn Centraal Veneuze Toegang

 

Geen.

Geen.

Geen.

Geen.

Geen.

Geen.

Geen restricties.

Marianne Elisabeth Sitsen

Anesthesioloog en medisch manager OK centrum

Richtlijn Centraal Veneuze Toegang

Geen.

Geen.

Geen.

Geen.

Geen.

Geen.

Geen restricties.

Marijke Molegraaf

Vaatchirurg

Richtlijn Centraal Veneuze Toegang

 

Geen.

Geen.

Geen.

Geen.

Geen.

Geen.

Geen restricties.

Michelle Gompelman

Internist-infectioloog,

Arts-onderzoeker

Richtlijn Centraal Veneuze Toegang

Hoofdredactieraad lid Tijdschrift voor Infectieziekten – onbetaald.

Geen.

Geen.

CARRIER-trial (ZonMW), Staphylococcus aureus decolonization in patients on home parenteral nutrition, geen PI.

Geen.

Geen.

Geen restricties. Extern gefinancierd onderzoek valt buiten bestek van de richtlijn.

 

Pum le Haen

Interventieradioloog

Richtlijn Centraal Veneuze Toegang

Geen.

Geen.

Geen.

Lokale P.I. voor onderzoek naar de verbeterde/snellere toegang tot de AFS bij antegrade punctie van de AFC met de Speedwire. Multi center internationale studie onder P.I-schap van D. van den Heuvel, interventieradioloog St Antonius Ziekenhuis in Nieuwegein. Voor de inclusie van een patiënt in het bovengenoemde onderzoek wordt een onkostenvergoeding van 100 euro betaald. Deze vergoeding loopt via het ziekenhuis en de specialisten coöperatie en wordt betaald door Speedwire. Gaat om in totaal 20-25 patiënten in de looptijd van het onderzoek.

Geen.

Geen.

Geen restricties. Extern gefinancierd onderzoek valt buiten bestek van de richtlijn.

Inbreng patiëntenperspectief

Er werd aandacht besteed aan het patiëntenperspectief door uitnodigen van de Patiëntenfederatie Nederland voor de invitational conference. Het verslag hiervan is besproken in de werkgroep. De verkregen input is meegenomen bij het opstellen van de uitgangsvragen, de keuze voor de uitkomstmaten en bij het opstellen van de overwegingen. De conceptrichtlijn is tevens voor commentaar voorgelegd aan de deelnemers van de invitational conference en de eventueel aangeleverde commentaren zijn bekeken en verwerkt.

 

Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz (Volgt na de commentaarfase)

Bij de richtlijnmodule is conform de Wet kwaliteit, klachten en geschillen zorg (Wkkgz) een kwalitatieve raming uitgevoerd om te beoordelen of de aanbevelingen mogelijk leiden tot substantiële financiële gevolgen. Bij het uitvoeren van deze beoordeling is de richtlijnmodule op verschillende domeinen getoetst (zie het stroomschema op de Richtlijnendatabase).

Module

Uitkomst raming

Toelichting

Echogeleid aanprikken

Geen substantiële financiële gevolgen

Uit de toetsing volgt dat de aanbevelingen mogelijk een kostenbesparend effect hebben doordat bij gebruik van echo bij het aanprikken van een vene het aantal pogingen en het aantal complicaties afneemt. Dit leidt tot het besparen van kosten op materiaal en interventies. Het gebruik van een echoapparaat brengt kosten met zich mee, maar met enkele apparaten kan worden volstaan om een heel ziekenhuis te ondervangen voor het inbrengen van centrale en perifere lijnen.

Werkwijze

AGREE

Deze richtlijnmodule is opgesteld conform de eisen vermeld in het rapport Medisch Specialistische Richtlijnen 2.0 van de adviescommissie Richtlijnen van de Raad Kwaliteit. Dit rapport is gebaseerd op het AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II; Brouwers, 2010).

 

Knelpuntenanalyse en uitgangsvragen

Tijdens de voorbereidende fase inventariseerde de werkgroep de knelpunten in de zorg voor patiënten met die een centraal veneuze lijn krijgen. Tevens zijn er knelpunten aangedragen via een invitational conference. Een verslag hiervan is opgenomen onder aanverwante producten. Op basis van de uitkomsten van de knelpuntenanalyse zijn door de werkgroep concept-uitgangsvragen opgesteld en definitief vastgesteld.

 

Uitkomstmaten

Na het opstellen van de zoekvraag behorende bij de uitgangsvraag inventariseerde de werkgroep welke uitkomstmaten voor de patiënt relevant zijn, waarbij zowel naar gewenste als ongewenste effecten werd gekeken. Hierbij werd een maximum van acht uitkomstmaten gehanteerd. De werkgroep waardeerde deze uitkomstmaten volgens hun relatieve belang bij de besluitvorming rondom aanbevelingen, als cruciaal (kritiek voor de besluitvorming), belangrijk (maar niet cruciaal) en onbelangrijk. Tevens definieerde de werkgroep tenminste voor de cruciale uitkomstmaten welke verschillen zij klinisch (patiënt) relevant vonden.

 

Methode literatuursamenvatting

Een uitgebreide beschrijving van de strategie voor zoeken en selecteren van literatuur is te vinden onder ‘Zoeken en selecteren’ onder Onderbouwing. Indien mogelijk werd de data uit verschillende studies gepoold in een random-effects model. [Review Manager 5.4] werd gebruikt voor de statistische analyses. De beoordeling van de kracht van het wetenschappelijke bewijs wordt hieronder toegelicht.

 

Beoordelen van de kracht van het wetenschappelijke bewijs

De kracht van het wetenschappelijke bewijs werd bepaald volgens de GRADE-methode. GRADE staat voor ‘Grading Recommendations Assessment, Development and Evaluation’ (zie http://www.gradeworkinggroup.org/). De basisprincipes van de GRADE-methodiek zijn: het benoemen en prioriteren van de klinisch (patiënt) relevante uitkomstmaten, een systematische review per uitkomstmaat, en een beoordeling van de bewijskracht per uitkomstmaat op basis van de acht GRADE-domeinen (domeinen voor downgraden: risk of bias, inconsistentie, indirectheid, imprecisie, en publicatiebias; domeinen voor upgraden: dosis-effect relatie, groot effect, en residuele plausibele confounding).

 

GRADE onderscheidt vier gradaties voor de kwaliteit van het wetenschappelijk bewijs: hoog, redelijk, laag en zeer laag. Deze gradaties verwijzen naar de mate van zekerheid die er bestaat over de literatuurconclusie, in het bijzonder de mate van zekerheid dat de literatuurconclusie de aanbeveling adequaat ondersteunt (Schünemann, 2013; Hultcrantz, 2017).

GRADE

Definitie

Hoog

  • er is hoge zekerheid dat het ware effect van behandeling dichtbij het geschatte effect van behandeling ligt;
  • het is zeer onwaarschijnlijk dat de literatuurconclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Redelijk

  • er is redelijke zekerheid dat het ware effect van behandeling dichtbij het geschatte effect van behandeling ligt;
  • het is mogelijk dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Laag

  • er is lage zekerheid dat het ware effect van behandeling dichtbij het geschatte effect van behandeling ligt;
  • er is een reële kans dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Zeer laag

  • er is zeer lage zekerheid dat het ware effect van behandeling dichtbij het geschatte effect van behandeling ligt;
  • de literatuurconclusie is zeer onzeker.

Bij het beoordelen (graderen) van de kracht van het wetenschappelijk bewijs in richtlijnen volgens de GRADE-methodiek spelen grenzen voor klinische besluitvorming een belangrijke rol (Hultcrantz, 2017). Dit zijn de grenzen die bij overschrijding aanleiding zouden geven tot een aanpassing van de aanbeveling. Om de grenzen voor klinische besluitvorming te bepalen moeten alle relevante uitkomstmaten en overwegingen worden meegewogen. De grenzen voor klinische besluitvorming zijn daarmee niet één op één vergelijkbaar met het minimaal klinisch relevant verschil (Minimal Clinically Important Difference, MCID). Met name in situaties waarin een interventie geen belangrijke nadelen heeft en de kosten relatief laag zijn, kan de grens voor klinische besluitvorming met betrekking tot de effectiviteit van de interventie bij een lagere waarde (dichter bij het nuleffect) liggen dan de MCID (Hultcrantz, 2017).

 

Overwegingen (van bewijs naar aanbeveling)

Om te komen tot een aanbeveling zijn naast (de kwaliteit van) het wetenschappelijke bewijs ook andere aspecten belangrijk en worden meegewogen, zoals aanvullende argumenten uit bijvoorbeeld de biomechanica of fysiologie, waarden en voorkeuren van patiënten, kosten (middelenbeslag), aanvaardbaarheid, haalbaarheid en implementatie. Deze aspecten zijn systematisch vermeld en beoordeeld (gewogen) onder het kopje ‘Overwegingen’ en kunnen (mede) gebaseerd zijn op expert opinion. Hierbij is gebruik gemaakt van een gestructureerd format gebaseerd op het evidence-to-decision framework van de internationale GRADE Working Group (Alonso-Coello, 2016a; Alonso-Coello 2016b). Dit evidence-to-decision framework is een integraal onderdeel van de GRADE methodiek.

 

Formuleren van aanbevelingen

De aanbevelingen geven antwoord op de uitgangsvraag en zijn gebaseerd op het beschikbare wetenschappelijke bewijs en de belangrijkste overwegingen, en een weging van de gunstige en ongunstige effecten van de relevante interventies. De kracht van het wetenschappelijk bewijs en het gewicht dat door de werkgroep wordt toegekend aan de overwegingen, bepalen samen de sterkte van de aanbeveling. Conform de GRADE-methodiek sluit een lage bewijskracht van conclusies in de systematische literatuuranalyse een sterke aanbeveling niet a priori uit, en zijn bij een hoge bewijskracht ook zwakke aanbevelingen mogelijk (Agoritsas, 2017; Neumann, 2016). De sterkte van de aanbeveling wordt altijd bepaald door weging van alle relevante argumenten tezamen. De werkgroep heeft bij elke aanbeveling opgenomen hoe zij tot de richting en sterkte van de aanbeveling zijn gekomen.

 

In de GRADE-methodiek wordt onderscheid gemaakt tussen sterke en zwakke (of conditionele) aanbevelingen. De sterkte van een aanbeveling verwijst naar de mate van zekerheid dat de voordelen van de interventie opwegen tegen de nadelen (of vice versa), gezien over het hele spectrum van patiënten waarvoor de aanbeveling is bedoeld. De sterkte van een aanbeveling heeft duidelijke implicaties voor patiënten, behandelaars en beleidsmakers (zie onderstaande tabel). Een aanbeveling is geen dictaat, zelfs een sterke aanbeveling gebaseerd op bewijs van hoge kwaliteit (GRADE gradering HOOG) zal niet altijd van toepassing zijn, onder alle mogelijke omstandigheden en voor elke individuele patiënt.

Implicaties van sterke en zwakke aanbevelingen voor verschillende richtlijngebruikers

 

 

Sterke aanbeveling

Zwakke (conditionele) aanbeveling

Voor patiënten

De meeste patiënten zouden de aanbevolen interventie of aanpak kiezen en slechts een klein aantal niet.

Een aanzienlijk deel van de patiënten zouden de aanbevolen interventie of aanpak kiezen, maar veel patiënten ook niet. 

Voor behandelaars

De meeste patiënten zouden de aanbevolen interventie of aanpak moeten ontvangen.

Er zijn meerdere geschikte interventies of aanpakken. De patiënt moet worden ondersteund bij de keuze voor de interventie of aanpak die het beste aansluit bij zijn of haar waarden en voorkeuren.

Voor beleidsmakers

De aanbevolen interventie of aanpak kan worden gezien als standaardbeleid.

Beleidsbepaling vereist uitvoerige discussie met betrokkenheid van veel stakeholders. Er is een grotere kans op lokale beleidsverschillen. 

Organisatie van zorg

In de knelpuntenanalyse en bij de ontwikkeling van de richtlijnmodule is expliciet aandacht geweest voor de organisatie van zorg: alle aspecten die randvoorwaardelijk zijn voor het verlenen van zorg (zoals coördinatie, communicatie, (financiële) middelen, mankracht en infrastructuur). Randvoorwaarden die relevant zijn voor het beantwoorden van deze specifieke uitgangsvraag zijn genoemd bij de overwegingen. Meer algemene, overkoepelende, of bijkomende aspecten van de organisatie van zorg worden behandeld in de module Organisatie van zorg.

 

Commentaar- en autorisatiefase

De conceptrichtlijnmodule werd aan de betrokken (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd ter commentaar. De commentaren werden verzameld en besproken met de werkgroep. Naar aanleiding van de commentaren werd de conceptrichtlijnmodule aangepast en definitief vastgesteld door de werkgroep. De definitieve richtlijnmodule werd aan de deelnemende (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd voor autorisatie en door hen geautoriseerd dan wel geaccordeerd.

 

Literatuur

Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 2017 Nov 16;7(11):e018593. doi: 10.1136/bmjopen-2017-018593. PubMed PMID: 29150475; PubMed Central PMCID: PMC5701989.

 

Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. PubMed PMID: 27353417.

 

Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089. doi: 10.1136/bmj.i2089. PubMed PMID: 27365494.

 

Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. Review. PubMed PMID: 20603348; PubMed Central PMCID: PMC3001530.

 

Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, Alper BS, Meerpohl JJ, Murad MH, Ansari MT, Katikireddi SV, Östlund P, Tranæus S, Christensen R, Gartlehner G, Brozek J, Izcovich A, Schünemann H, Guyatt G. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. doi: 10.1016/j.jclinepi.2017.05.006. Epub 2017 May 18. PubMed PMID: 28529184; PubMed Central PMCID: PMC6542664.

 

Medisch Specialistische Richtlijnen 2.0 (2012). Adviescommissie Richtlijnen van de Raad Kwalitieit. http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html

 

Neumann I, Santesso N, Akl EA, Rind DM, Vandvik PO, Alonso-Coello P, Agoritsas T, Mustafa RA, Alexander PE, Schünemann H, Guyatt GH. A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. J Clin Epidemiol. 2016 Apr;72:45-55. doi: 10.1016/j.jclinepi.2015.11.017. Epub 2016 Jan 6. Review. PubMed PMID: 26772609.

 

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.

Zoekverantwoording

Zoekacties zijn opvraagbaar. Neem hiervoor contact op met de Richtlijnendatabase.

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