Contrastmiddeltoediening door middel van power injectors
Uitgangsvraag
Hoe kunnen centraal veneuze katheters (CVC), hemodialyse katheters (HC), perifeer ingebrachte centrale katheters (PICC), en totally implantable venous access devices (TIVAD, poorten) veilig worden gebruikt voor het toediening van intraveneuze contrastmiddelen (CM), in het bijzonder bij het gebruik van power injectors en hogere injectiesnelheden voor het verkrijgen van afbeeldingen van hoge kwaliteit?
Aanbeveling
Opmerking: Hoge beeldkwaliteit is meestal nodig bij laag-contrast situaties, zoals bij (stagerings)onderzoeken in de hersenen, in het hoofd-hals gebied of bij hepatobiliaire, genito-urinaire of colorectale onderzoeken in het abdomen. Lagere beeldkwaliteit kan acceptabel zijn in hoog-contrast situaties zoals bij pulmonaire of musculoskeletale beeldvorming, of bij de follow-up van lymfeklieren (bv. lymfomen, testiscarcinoom).
| Gebruik een power-injector en perifere veneuze katheter voor intraveneuze CM toediening om de beste kwaliteit van beeldvorming na contrasttoediening te verkrijgen, vooral in laag-contrast situaties (zie Opmerking). |
| Controleer voor én na CM toediening met een power injector de positie en doorgankelijkheid van een CVC, TIVAD of PICC lijn wanneer een perifere veneuze katheter niet beschikbaar is. |
| Power-injecteerbare centraal veneuze katheters kunnen veilig worden gebruikt voor de toediening van CM met een power-injector wanneer de meeste recente aanbevelingen van de fabrikant van de katheter worden opgevolgd. |
| Power-injecteerbare hemodialyse katheters kunnen veilig worden gebruikt voor de toediening van CM met een power-injector wanneer de meest recente aanbevelingen van de fabrikant van de katheter worden opgevolgd. |
| Wanneer CM wordt geïnjecteerd met een power-injector bij patiënten met een PICC lijn of TIVADs waarvan de kathertertip boven de tracheobronchiale hoek ligt is er risico op migratie van de kathetertip van deze lijnen. Controleer daarom bij een PICC of TIVAD met kathetertip boven de tracheobronchiale hoek de positie van de kathetertip met een röntgenfoto, CT instelopname, of doorlichting voor én na CM toediening met een power injector. |
|
Wanneer een voor power-injectie geschikte CVC, HC, PICC of TIVAD wordt gebruikt voor CM toediening met een power-injector, controleer dan of de katheter nog open is door handmatig te spoelen met 20 ml fysiologisch zout na de injectie
Wanneer een voor power-injectie geschikte HC wordt gebruik voor CM toediening met een power injector, moet een patient-specifieke oplossing om de catheter af te sluiten direct na injectie worden aangelegd door een gecertifceerde dialyse verpleegkundige. |
| Zie Appendix 1 voor aanbevelingen over stroomsnelheden en injectiedruk voor een groot aantal commercieel beschikbare CVC's, HC's, PICC's en TIVAD's in Nederland. |
Overwegingen
A patent intravenous access site is needed for the administration of intravenous contrast through power injection in order to obtain high quality contrast enhanced or angiographic images. Local hospital guidelines should be available to guide the proper and safe administration technique for the applied contrast medium, but these a frequently limited to peripheral venous injection only. Possible complications of IV contrast injection are: contrast medium extravasation, air embolism, catheter rupture, catheter weakening, and loss of catheter patency.
With the use of power injectors, injection pressure is also a function of the injected CM. In general, the use of lower concentrations of the CM, low viscosity of the CM, and high temperature of CM are beneficial to keep injection pressures as low as possible (Macha, 2009; Kok, 2014). There are only a limited number of studies that compare the safety and efficacy of different venous access sites. No difference is reported in patency between CVCs or peripheral venous access catheters, however there seems to be a difference in the level of the contrast enhancement of large vessels, which affects the image quality in favour of a peripheral venous access. A short peripheral IV catheter in the antecubital or forearm is therefore the preferred route for contrast administration. However other routes may be needed and each is considered separately below.
Central Venous Catheters (CVC)
In the comparative studies, there is no difference in reported complications in terms of patency related to the contrast medium power injection compared to peripheral venous access sites. However, image quality is limited compared to peripheral venous access sites.
Herts (Herts, 1996) also performed an in vitro study with 10F Hickman and Leonard CVCs, and found that CM, flow rate and catheter type were main determinants of peak injection pressures. The peak injection pressures remained well within manufacturer limits of 25 psi (175 kPa).
In an in vitro study with a 3-lumen 16G (4.9F) Arrow CVC, a significant safety margin was shown for CVCs, with bursting pressures depending on catheter dwell time, 262 PSI for new and 213 PSI for used catheters. Lowest flow rate associated with bursting was 9 ml/s. Ruptures occurred always outside the patient (Macha, 2009). Similar high bursting pressures were seen in other studies. A study using 3-lumen 16G CVCs showed pressure to be above 175 PSI, whereas high flow injections 4,5 to 7,0 ml/s were associated with injection pressures of 48 to 81 PSI (Beckingham, 2017). An older study found no catheter failures at flow rates of 5 to 25ml/s with an even higher bursting pressure of 920 psi (Zamos, 2007).
To help prevent the rupture of vascular access devices when they are used with power injectors, the FDA long ago has already issued recommendations (FDA, 2004).
Users of central vascular access devices should:
- Check the labelling of each vascular access device for its maximum pressure and flow rate. If none is provided, assume device is NOT intended for power injection and do not use.
- Know the pressure limit setting for your power injector and how to adjust it.
- Ensure that the pressure limit set for the power injector does not exceed the maximum labelled pressure for the vascular access device(s).
Haemodialysis Catheters (HC)
There are no patient controlled studies available that compare the usability and safety of dialysis catheters for IV contrast administration through power injection versus peripheral IV catheters or central venous catheters. However, haemodialysis catheters have larger diameters than other venous catheters. An in vitro study on cuffed and non-cuffed catheters for haemodialysis showed that pressure inside the catheters (14,0 ± 3,3 PSI) was 23x lower than the pressures indicated by the power injectors (338 ± 8,7 PSI). It is believed that the high pressures in the injector are mainly caused by the long, small calibre connection tubing that connects the injector to the HC (Hollander, 2012). Therefore, their use for power injection should be safe when adhering to the recommendations of the manufacturer. Adjustments to the scan protocol may be needed to preserve optimal image quality. Especially in chronic dialysis patients with poor vascular conditions vein preservation has a high priority.
Peripherally inserted catheters (PICC)
Spontaneous migration of PICCs is a known complication in 1.5 to 3% with multifactorial aetiology (Seckold, 2015). Multiple other case series have confirmed that the catheter tip of power-injectable PICCs can migrate due to the power injection during CT (Lambeth, 2012; Craigie, 2018). Tubing ruptures during power injection are reported when there is a mechanical obstruction such as a clamped port or kinking of the line. Silicone catheters are have higher failure rates than polyurethane catheters and are unsuitable for power injection (Salis, 2004). Strict protocols are recommended to check its position via CT scout/scanogram radiograph before and after power injection during CT, and to check patency of the catheter after CM injection.
Totally Implantable Venous Access Devices (TIVAD)
A retrospective analysis of TIVADs with silicone catheters showed a 3.4% rate of complications (Busch 2012; Busch, 2017). Newer power-injectable TIVADs have a high patient satisfaction rate and with no device failures during power injections (Alexander, 2012; Chang, 2013).
There are no data on catheter tip migration in TIVADs, mainly because they are tunneled catheters inserted surgically with a deep position of the catheter tip. Theoretically, for devices with high positions of the catheter tip, the same risks for migration as in PICCs would exist.
The GAVeCeLT group formulated already in 2011 recommendations to prevent complications with TIVADs and recommends only using systems specifically suitable for power injection with adequate check of catheter position (Bonciarelli, 2011.
A Canadian study on CT image quality showed that contrast injection via a CVC or port system has equivalent image quality when compared to conventional peripheral intravenous injection technique. (Haggag, 2016)
Onderbouwing
Achtergrond
Power injection of contrast through CVCs, HCs, PICCs, and TIVADs holds a risk for device failure and secondary contrast extravasation. The exact method how to "power-inject" with respect to applied pressure limitations remains part of local practice guidelines combined with the central catheter line manufacturer's instructions.
Conclusies
|
Very Low GRADE |
The frequency of complications following contrast injection via CVCs, without safety protocols, varies from 0,6% to 15,4% across studies.
Sources: (Coyle, 2004; Goltz, 2011; Herts, 2001; Lozano, 2012; Morden, 2014) |
|
Very Low GRADE |
It seems that contrast injections via CVCs are a safe alternative to peripheral injection if safety protocols are followed.
Sources: (Coyle, 2004; Goltz, 2011; Herts, 2001; Lozano, 2012; Morden, 2014) |
|
Very Low GRADE |
There were no complications reported following contrast injection via CVCs when strict safety protocols were implemented.
Sources: (Macht, 2012 and Sanelli, 2004) |
|
Very Low GRADE |
Safety protocols are warranted when contrast injections are performed via central venous catheters, and should include aspirating blood before injecting contrast media, localizing the CVC before and after injection, making sure no kinking of the CVC and attached lines occurs, using sterile syringes, and making sure the CVC is patent after scanning.
Sources: (Macht, 2012 and Sanelli, 2004) |
|
Very Low GRADE |
It is unknown whether contrast injections via CVCs result in successful contrast media examination as quality of scans varies among studies.
Sources: (Coyle, 2004; Goltz, 2011 and Herts, 2001) |
|
Very low. GRADE |
It seems that power injectable PICCs positioned in the proximal SVC (cephalic to tracheobronchial angle) before contrast administration had a higher risk of displacement compared to catheters positioned in the distal SVC (caudal to tracheobronchial angle) before contrast administration.
Source: (Lozano, 2012) |
Samenvatting literatuur
Buijs (2017) described a systematic literature review on the efficacy of contrast injection via central venous catheters for contrast enhanced computed tomography. A search query was built by linking two content areas: ‘central catheter’ and ‘contrast enhanced’ with relevant synonyms for both areas. Publications were selected, describing original research on the use of CVCs for contrast administration for CT-scans focusing on safety, efficacy, and complications. Exclusion criteria included: no full-text available, publication not written in English or Dutch, review articles, case reports, and studies focusing on the use of CVCs in paediatrics. Two independent assessors screened titles and abstracts for full-text selection. Studies were classified as having low risk of bias if they satisfied all criteria and high risk of bias if they satisfied less than three criteria. The remaining studies were classified as having a moderate risk of bias. (See risk of bias assessment). Frequencies of complications were extracted from the selected studies were tabulated and presented as percentages. Data on quality of images was extracted where applicable. Twenty-three articles were considered eligible for answering the research question after selection based on title and abstract. Seventeen articles were excluded during full text screening. During cross-referencing, one study was included missed by the initial search (Carlson, 1992; Goltz, 2011). Eventually, eight studies were included for critical appraisal (Coyle, 2004; Goltz, 2011; Herts, 2001; Lozano, 2012; Macht, 2012; Morden, 2014; Sanelli, 2004). Carlson (1992) evaluated the system pressure in thirteen patients with a Port-A-Cath. The pressure measurement was not standardized: five patients’ injection pressures were measured with a pressure gauge that was placed in-line during injection and eight patients’ injection pressures were not. The lack of standardization and limited relevance led to the exclusion of this study. Finally, seven studies were included for further analysis (Coyle, 2004; Goltz, 2011; Herts, 2001; Lozano, 2012; Macht, 2012; Morden, 2014; Sanelli, 2004). Table 11.1 presents study characteristics and main outcome measures on safety and image quality. Individual outcome measures among studies on safety and efficacy are described separately.
Results
1. Complications following contrast injection via central catheters
Central Venous Catheters (CVC)
Herts (2001) randomized 225 patients, after reassignment because of inability to obtain access, in a central venous access group (n= 174) and a peripheral venous access group (n= 51). No significant differences in early, delayed, and late complications were found. In the central venous access group, one (1/174; 0.6%) patient reported that her device was no longer patent, while being successfully used for chemotherapy after contrast injection. In one (1/174; 0.6%) patient an infection was reported. Macht (2012) and Sanelli (2004) implemented a strict safety protocol, in which they verified the correct position of the CVC in the superior vena cava (SVC) on scout view before contrast injection, checked for adequate blood return, and checked the patency of the catheter afterwards. They did not report complications relating to the injection using the CVC.
Peripherally inserted catheters (PICC)
Coyle (2004) found two (2/110; 1.8%) externally ruptured PICCs while injected at a rate of 2 mL/sec. Ruptures were caused by mechanic obstructions; i.e. one of the ruptured PICCs was clamped, the other kinked at the venous entry site. Another PICC ballooned without rupturing and further injected was stopped.
Lozano (2012) evaluated the frequency of displacement of power-injectable PICC (PI-PICC) after contrast injection. Correct catheter position was defined as cephalic to or caudal to the right tracheobronchial angle. A total of 12/78 (15.4%) PI-PICC tips changed in position after injection of contrast medium. Seven displaced toward the brachiocephalic veins. They found that PI-PICCs positioned in the proximal SVC (cephalic to tracheobronchial angle) before contrast administration had a higher risk of displacement compared to catheters positioned in the distal SVC (caudal to tracheobronchial angle) before contrast administration (5/8 (62.5%) versus 7/69 (10.1%)). Distal location in the SVC decreased this risk by 89% (RR= 0.11; 95%CI= (0,026; 0,487); p= 0.006).
Morden (2014) evaluated a rate increase technique of the saline flush after contrast injection via power-injectable PICCs (PI-PICC), in which they started with a saline flush at 2 mL/s and progressively increased to the rate of contrast injection. With this technique, they found a lower percentage of PI-PICC tip displacement (20/243 (8.2%) without rate increase technique versus. 3/138 (2.2%) with rate increase technique).
Totally Implantable Venous Access Devices (TIVAD)
Goltz (2011) evaluated power injections in 141 patients with totally implantable venous access ports (TIVADs) in their forearm. One (1/141; 0.7%) TIVAD catheter tip was dislocated into the brachiocephalic vein and revealed a catheter rupture during an interventional retrieval attempt. Three (3/141; 2.1%) catheter tips were suspected of a systemic infection within four weeks.
2. Contrast enhancement and image quality
Central Venous Catheters (CVC)
In Herts (2001), two reviewers who were blinded for route of injection measured the enhancement of the large vessels. The level of enhancement of the thoracic aorta, pulmonary artery, and liver vasculature was significantly less dense in the central venous access group compared to the peripheral venous access group. No significant difference was seen in the enhancement of the abdominal aorta.
Totally Implantable Venous Access Devices (TIVAD)
In Coyle (2004) CT images were assessed subjectively by the radiologist supervising the CT examination, which resulted in categorizing the quality of CT images as average in 81/110 (74%) of cases and above average in 23/110 (21%) of cases.
Goltz (2011) found a significantly lower arterial contrast density in patients with TIVADs compared with classic peripheral cannula, resulting in limited image quality. In 31/44 (70.4%) examinations, manual initialization was necessary, while initial arterial bolus tracking was performed, because the trigger threshold had not been reached in time. This might be the result of the lower flow rate of 1.5 mL/s through TIVADs. Triggering with automatic scan initiation resulted in significantly higher contrast in the aorta compared to manual scan initiation (163 HU versus 144 HU, p =0.039).
Quality of evidence
The quality of certainty of evidence was graded as very low due to high risk of bias (see Table Risk of Bias assessment, downgraded by one point) and low number of patients (imprecision, downgraded by two points) and lack of studies where a control group was present.
Zoeken en selecteren
A systematic literature analysis was performed to answer the research question: How can central venous catheters (CVC), haemodialysis catheters (HC), peripherally inserted central catheters (PICC), and totally implantable venous access devices (TIVAD) be safely used for the administration of intravenous contrast agents, particularly using power injectors and higher injection rates for obtaining high-quality images?
P (Patient): Patients with central venous catheters (CVCs) or Peripheral inserted central catheters (PICCs) and an indication for administration of iodine-based contrast for performing computed tomography examinations.
I (Intervention): Non-tunneled central venous catheters (CVCs), tunneled CVCs, implantable ports, peripherally inserted central catheters (PICC).
C (Comparison): Normal Venflon, normal peripheral infusion.
O (Outcomes): Failure contrast media examination, contrast extravasation, failure of examination, damaged CVCs or PICCs, complication rates, device failure, and device dwell times.
Relevance of outcome measures
The working group considered the outcomes failure of contrast media examination, complication rates (damaged CVCs or PICCs, contrast media extravasation) critical measures and outcome for the decision making process. The working group did not define criteria for outcomes a priori, but used the outcomes as defined in the studies.
Methods
The databases Medline (OVID), Embase and the Cochrane Library were searched from 1st of January 1996 to March 2018 using relevant search terms for systematic reviews (SRs), randomized controlled trials (RCTs) and observational studies (OBS). A systematic literature search was conducted at May 16th 2018.
The literature search produced 97 hits: 2 SR, 13 RCTs and 13 OBS and 68 mixed designs. Based on title and abstract a total of 18 studies were selected. After examination of full text 0 articles were selected. Since there are no direct comparisons on the safety or efficacy of contrast injections via central venous catheters or peripheral inserted central catheters (PICCs) versus normal infusion, literature has been described in a descriptive manner. The SR of Buijs, 2017 was selected and covers the literature on efficacy and safety of contrast injection via central venous catheters for contrast enhanced computed tomography until September 10th 2016. This study was used as key article for the literature review. Studies published after September 10th 2016, on efficacy and safety of contrast injection via central venous catheters or peripheral inserted central catheters were added.
Referenties
- Alexander MD, Morrison HL. Power-injectable ports: safety during placement, therapeutic use, and contrast administration during computed tomography procedures. J Vasc Access 2012; 13: 432-437.
- Beckingham T, Roberts A, St John A, O'Callaghan G. Bursting pressure of triple-lumen central venous catheters under static and dynamic loads. J Vasc Access 2017; 18: 430-435.
- Buijs SB, Barentsz MW, Smits MLJ, Gratama JWC, Spronk PE. Systematic review of the safety and efficacy of contrast injection via venous catheters for contrast-enhanced computed tomography. Eur J Radiol Open 2017; 4: 118-122.
- Bonciarelli G, Batacchi S, Biffi R, et al. Gruppo Aperto di Studio Accessi Venosi Centrali a Lungo Termine (Study Group on Long-Term Central Venous Access). GAVeCeLT* consensus statement on the correct use of totally implantable venous access devices for diagnostic radiology procedures. J Vasc Access. 2011; 12: 292-305.
- Burbridge BE, Adams S, Burbridge C. Computed tomography frequency and power injection utilization for a cohort cancer patients with arm ports. J Radiol Med Imaging 2018; 1: 1002.
- Busch JD, Herrmann J, Heller F, Derlin T, Koops A, Adam G, Habermann CR. Follow-up of radiologically totally implanted central venous access ports of the upper arm: long-term complications in 127,750 catheter-days. AJR Am J Roentgenol 2012; 199: 447-452.
- Busch JD, Vens M, Herrmann J, Adam G, Ittrich H. Material failure of silicone catheter lines: a retrospective review of partial and complete ruptures in 553 patients. AJR Am J Roentgenol 2017; 208: 464-469.
- Chang DH, Kabbasch C, Bovenschulte H, Libicher M, Maintz D, Bangard C. Experiences with power-injectable port systems: complications, patient satisfaction and clinical benefit (in German). RöFo Fortschr Röntgenstr 2013; 185: 454-460.
- Coyle D, Bloomgardeb D, Beres R, Patel S, Sane S, Hurst E. Power Injection of contrast media via peripherally inserted central catheters for CT. J Vasc Interv Radiol 2004; 15: 809-814.
- Craigie M, Meehan L, Harper J. Tip migration post-contrast pressure injection through pressure-injectable peripherally inserted central catheters causing vascular injury: a report of 3 cases. Cardiovasc Intervent Radiol 2018; 41: 509-512.
- Food and Drug Administration. FDA Warns of Dangers of Misusing Vascular Access Devices. Bethesda MD, FDA, 2004. Available at: https://gavecelt.it/nuovo/sites/default/files/uploads/fda_warns_of_dangers_of_misusing_vascular_access_devices.pdf. Accessed: 11 July 2019.
- Goltz JP, Noack C, Petrisch B, Kirchner J, Hahn D, Kickuth R. Totally implantable venous power ports of the forearm and the chest: initial clinical experience with port devices approved for high-pressure injections. Br J Radiol 2012: 85: e966-e972.
- Haggag H, Roh C, Chan I, Burbridge B, Leswick D. Quality of computed tomography images acquired with power injection of an arm port. Can Assoc Radiol J 2016; 67: 112-114.
- Herts BR, O’Malley CM, Wirth SL, Lieber ML, Pholman B. Power injection of contrast media using central venous catheters: feasibility, safety and efficacy. AJR Am J Roentgenol 2001; 176: 447- 453.
- Hollander S, Mojibian H, Emery M, Tal MG. Power injection of iodinated intravenous contrast material through acute and chronic hemodialysis catheters. J Vasc Access 2012; 13: 61-64.
- Klee SJ. The ideal use of the power injectable peripherally inserted central catheter in the pediatric population. JAVA 2011; 16: 86-93.
- Kok M, Mihl C, Mingels AA, Kietselaer BL, Mühlenbruch G, Seehofnerova A, et al. Influence of contrast media viscosity and temperature on injection pressure in computed tomographic angiography: a phantom study. Invest Radiol 2014; 49: 217-223
- Lambeth L, Goyal A, Tadros A, Asadoorian M, Roberts AC, Karimi A. Peripherally inserted central catheter tip malposition caused by power contrast medium injection. J Vasc Interv Radiol 2012; 23: 981-983.
- Lozano LA, Marn C, Goodman LR. Power injectable peripherally inserted venous catheter lines frequently flip after power injection of contrast. J Comput Assist Tomogr 2012; 36: 427-430.
- Macha DB, Nelson RC, Howle LE, Hollingsworth JW, Schindera ST. Central venous catheter integrity during mechanical power injection of iodinated contrast medium. Radiology 2009; 253: 870-878.
- Macht S, Beseoglu K, Eicker S, Rybacki K, Braun S, Mathys C, et al. Safety and feasibility in highly concentrated contrast material power injections for CT-perfusion studies of the brain using central venous catheters. Eur J Radiol 2012; 81: 1883-1885.
- Morden P, Sokhandon F, Miller L, Savin M, Kirsch M, Farah M, et al. The Role of saline flush injection rate in displacement of CT-injectable peripherally inserted central catheter tip during power injection of contrast material. AJR Am J Roentgenol 2014; 202: W13-W18.
- Salis AI, Eclavea A, Johnson MS, Patel NH, Wong DG, Tennery G. Maximal flow rates possible during power injection through currently available PICCs: an in vitro study. J Vasc Interv Radiol 2004; 15: 275-281.
- Sanelli PC, Deshmukh M, Ougorets I, Caiati R, Heier LA. Safety and feasibility of using a central venous catheter for rapid contrast injection rates. AJR Am J Roentgenol 2004; 183: 1829-1834.
- Seckold T, Walker S, Dwyer T. A comparison of silicone and polyurethane PICC lines and postinsertion complication rates: a systematic review. J Vasc Access 2015; 16:167-177.
- Schummer C, Sakr Y, Steenbeck J, Gugel M, Reinhart K., Schummer W. Risk of extravasation after power injection of contrast media via the proximal port of multilumen central venous catheters: case report and review of the literature. RöFo Fortschr Rontgenstr 2010; 182: 14-19.
- Teichgräber UKM, Nagel SN, Kausche S, Enzweiler C. Clinical benefit of power injectable port systems: A prospective observational study. Eur J Radiol 2012; 81: 528-533.
- Verity R, Leswick D, Burbridge B, Bryce R, Lim H. Quality of computed tomography pulmonary embolism and aortic phase images acquired with power injection via an arm port. JAVA 2017; 22; 88-92.
- Weinbeck S, Fischbach R, Kloska SP, Seidensticker P, Osada N, Heindel W, et al. Prospective study of access site complications of automated contrast injection with peripheral venous access in MDCT. AJR Am J Roentgenol 2010: 195: 825- 829.
- Zamos DT, Emch TM, Patton HA, D'Amico FJ, Bansal SK. Injection rate threshold of triple-lumen central venous catheters: an in vitro study. Acad Radiol 2007; 14: 574-578.
Evidence tabellen
Not applicable, none of the studies fulfilled the inclusion criteria of the PICO.
Table Exclusion after full text review
|
Author and Year |
Reasons for exclusion |
|
Alexander, 2012 |
No full text available |
|
Coyle, 2004 |
Included in SR Buijs, 2017 |
|
Goltz, 2011 |
Included in Buijs, 2017 |
|
Goltz, 2012 |
Included in Buijs, 2017 |
|
Hardie, 2014 |
Does not fulfil PICO-criteria |
|
Herts, 2001 |
Included in SR Buijs, 2017 |
|
Kaste, 1996 |
Does not fulfil PICO-criteria |
|
Klee, 2011 |
Does not fulfil PICO-criteria: paediatric population |
|
Macht, 2012 |
Included in Buijs, 2017 |
|
Morden, 2014 |
Included in Buijs, 2017 |
|
Teichgräber, 2011 |
Does not fulfil PICO-criteria |
|
Uslusoy, 2008 |
Does not fulfil PICO-criteria |
|
Verity, 2017 |
Small sample size |
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 24-06-2020
Laatst geautoriseerd : 24-06-2020
Geplande herbeoordeling : 01-01-2025
Validity
The board of the Radiological Society of the Netherlands will determine at the latest in 2024 if this guideline (per module) is still valid and applicable. If necessary, a new working group will be formed to revise the guideline. The validity of a guideline can be shorter than 5 years, if new scientific or healthcare structure developments arise, that could be seen as a reason to commence revisions. The Radiological Society of the Netherlands is considered the keeper of this guideline and thus primarily responsible for the actuality of the guideline. The other scientific societies that have participated in the guideline development share the responsibility to inform the primarily responsible scientific society about relevant developments in their field.
Initiative
Radiological Society of the Netherlands
Authorization
The guideline is submitted for authorization to:
- Association of Surgeons of the Netherlands
- Dutch Association of Hospital Pharmacists
- Dutch Federation of Nephrology
- Dutch Society for Allergology and Clinical Immunology
- Dutch Society for Dermatology and Venereology
- Dutch Society of Intensive Care
- Netherlands Association of Internal Medicine
- Netherlands Society of Cardiology
- Netherlands Society of Emergency Physicians
- Netherlands Society of Intensive Care
- Radiological Society of the Netherlands
Algemene gegevens
General Information
The guideline development was assisted by the Knowledge Institute of the Federation Medical Specialists (www.kennisinstituut.nl) and was financed by the Quality Funds for Medical Specialists (Stichting Kwaliteitsgelden Medisch Specialisten: SKMS).
Doel en doelgroep
Goal
The aim of the Part 2 of Safe Use of Contrast Media guidelines is to critically review the present recent evidence with the above trend in mind and tries to formulate new practical guidelines for all hospital physicians to provide the safe use of contrast media in diagnostic and interventional studies. The ultimate goal of this guideline is to increase the quality of care, by providing efficient and expedient healthcare to the specific patient populations that may benefit from this healthcare and simultaneously guard patients from ineffective care. Furthermore, such a guideline should ideally be able to save money and reduce day-hospital waiting lists.
Users
This guideline is intended for all hospital physicians that request or perform diagnostic or interventional radiologic or cardiologic studies for their patients in which CM are involved.
Samenstelling werkgroep
Working group members
A multidisciplinary working group was formed for the development of the guideline in 2016. The working group consisted of representatives from all relevant medical specialization fields that are involved with intravascular contrast administration.
All working group members have been officially delegated for participation in the working group by their scientific societies. The working group has developed a guideline in the period from May 2016 until July 2019.
The working group is responsible for the complete text of this guideline.
Working group
Brummer I., emergency physician, Treant Healthcare Group, Emmen
de Geus H.R.H., internist-intensivist, Erasmus Medical Centre, Rotterdam
de Monchy J.G.R., allergologist, DC-Klinieken, Amsterdam
Dekker H.M., radiologist, Radboud University Medical Centre, Nijmegen
Dekkers I.A., clinical epidemiologist and radiologist in training, Leiden University Medical Centre, Leiden
Geenen R.W.F., radiologist, Noordwest Ziekenhuisgroep (NWZ), Alkmaar
Gotte M., cardiologist, Free University Medical Centre, Amsterdam (from July 2018)
Kardaun S.H., dermatologist, University Medical Centre Groningen, Groningen (until March, 2018)
Leiner T., radiologist, University Medical Centre Utrecht, Utrecht (until November 2018)
van der Molen A.J., radiologist, Leiden University Medical Centre, Leiden (chairman)
van der Putten K., nephrologist, Tergooi, Hilversum
van der Vlugt M., cardiologist, Radboud University Medical Centre, Nijmegen (until April 2018)
Wikkeling O.R.M., vascular surgeon, Heelkunde Friesland Groep, location: Nij Smellinghe Hospital, Drachten
Zielhuis S.W., hospital pharmacist, Medical Centre Leeuwarden, Leeuwarden
Methodological support
Buddeke J., advisor, Knowledge Institute of the Federation Medical Specialists (from April 2018)
Harmsen W., advisor, Knowledge Institute of the Federation Medical Specialists (from April 2018)
Mostovaya I.M., senior advisor, Knowledge Institute of the Federation Medical Specialists
Belangenverklaringen
Conflicts of interest
The working group members have provided written statements about (financially supported) relations with commercial companies, organisations or institutions that are related to the subject matter of the guideline. Furthermore, inquiries have been made regarding personal financial interests, interests due to personal relationships, interests related to reputation management, interest related to externally financed research and interests related to knowledge valorisation. The statements on conflict of interest can be requested at the administrative office of the Knowledge Institute of Medical Specialists and are summarised below.
|
Last name |
Function |
Other positions |
Personal financial interests |
Personal relations |
Reputation management |
Externally financed research |
Knowledge valorisation |
Other interests |
Signed |
|
Brummer |
Emergency physician |
None |
None |
None |
None |
None |
None |
None |
February 23rd, 2018 |
|
De Geus |
Internist-Intensivist Erasmus MC Rotterdam |
None |
None |
None |
None |
None |
None |
None |
March 31st, 2016 |
|
Dekker |
Radiologist |
None |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
July 10th, 2016 |
|
Dekkers |
Radiologist in training and PhD-candidate |
None |
None |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
July 8th, 2016 |
|
Geenen |
Radiologist |
Member of commission prevention of PC-AKI |
None |
None |
None |
None |
None |
Has held several presentation about contrast media on invitation (GE, BAYER) |
March 25th, 2016 |
|
Kardaun |
Dermatologist – researcher Universitair Medisch Centrum Groningen: unpaid |
Replacing dermatologist in clinical practice - unpaid |
None |
None |
None |
None |
None |
None |
February 24th, 2016 |
|
Roodheuvel |
Emergency physician |
Instructor OSG/VvAA for courses on echography – paid position Member of department for burn treatment – unpaid. |
None |
None |
None |
None |
None |
None |
December 21st, 2015 |
|
Van der Molen |
Chairman |
None |
None |
None |
None |
None |
Not applicable |
One-off royalties Springer Verlag (2014) Incidental payments for presentations or being day chairman at contrast safety congress (2016 Netherlands + Europe |
September 6th, 2016 |
|
Van der Putten |
Internist nephrologist |
None |
None |
None |
None |
None |
None |
None |
October 14th, 2015 |
|
Van der Vlugt |
Cardiologist |
None |
None |
None |
Chairman of the working group Cardiac MRI & CT and Nuclear imaging of the Netherlands Society of Cardiology |
None |
None |
None |
March 1st, 2016 |
|
Wikkeling |
Vascular surgeon |
None |
None |
None |
None |
None |
None |
Not applicable |
July 19th, 2016 |
|
Zielhuis |
Hospital pharmacist |
None |
In the past (2013-2015) has participated in an advisory panel on expensive medication for the companies AbbVie and Novartis. Has received an expense allowance for this. Both forms do not produce contrast media that this guideline is about. Currently not active in an advisory panel. |
None |
None |
None |
None |
None |
January 8th, 2016 |
Inbreng patiëntenperspectief
Input of patient’s perspective
It was challenging to find representation for the patient’s perspective, since the guideline does not discuss a specific group of patients with a disease. The Dutch Kidney Patients Association was invited to participate in an advisory board to the working group, but declined since this subject was not specific enough for them to give adequate input; The Dutch Kidney Patients Association did provide written feedback for specific modules during the commentary phase. The Dutch Kidney Patients Association and the Patient Federation of the Netherlands was invited to participate in the invitational conference in which the framework of the guideline was discussed. Furthermore, the concept guideline has been submitted for feedback during the comment process to the Patient Federation of the Netherlands and the Dutch Kidney Patient Association.
Methode ontwikkeling
Evidence based
Implementatie
Implementation
In the different phases of guideline development, the implementation of the guideline, and the practical enforceability of the guideline were taken into account. The factors that could facilitate or hinder the introduction of the guideline in clinical practice have been explicitly considered. The implementation plan can be found with the Related Products. Furthermore, quality indicators were developed to enhance the implementation of the guideline. The indicators can also be found with the Related Products.
Werkwijze
Methodology
AGREE
This guideline has been developed conforming to the requirements of the report of Guidelines for Medical Specialists 2.0 by the advisory committee of the Quality Counsel (www.kwaliteitskoepel.nl). This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (www.agreetrust.org), a broadly accepted instrument in the international community and on the national quality standards for guidelines: “Guidelines for guidelines” (www.zorginstituutnederland.nl).
Identification of subject matter
During the initial phase of the guideline development, the chairman, working group and the advisor inventory the relevant subject matter for the guideline. Furthermore, an Invitational Conference was organized, where additional relevant subjects were discussed. A report of this meeting can be found in Related Products.
Clinical questions and outcomes
During the initial phase of guideline development, the chairman, working group and advisor identified relevant subject matter for the guideline. Furthermore, input was acquired for the outline of the guideline during an Invitational Conference. The working group then formulated definitive clinical questions and defined relevant outcome measures (both beneficial land harmful effects). The working group rated the outcome measures as critical, important and not important. Furthermore, where applicable, the working group defined relevant clinical differences.
Strategy for search and selection of literature
For the separate clinical questions, specific search terms were formulated and published scientific articles were sought after in (several) electronic databases. Furthermore, studies were scrutinized by cross-referencing for other included studies. The studies with potentially the highest quality of research were looked for first. The working group members selected literature in pairs (independently of each other) based on title and abstract. A second selection was performed based on full text. The databases, search terms and selection criteria are described in the modules containing the clinical questions.
Quality assessment of individual studies
Individual studies were systematically assessed, based on methodological quality criteria that were determined prior to the search, so that risk of bias could be estimated. This is described in the “risk of bias” tables.
Summary of literature
The relevant research findings of all selected articles are shown in evidence tables. The most important findings in literature are described in literature summaries. When there were enough similarities between studies, the study data were pooled.
Grading quality of evidence and strength of recommendations
The strength of the conclusions of the scientific publications was determined using the GRADE-method. GRADE stands for Grading Recommendations Assessment, Development and Evaluation (see http://www.gradeworkinggroup.org/) (Atkins, 2004).
GRADE defines four gradations for the quality of scientific evidence: high, moderate, low or very low. These gradations provide information about the amount of certainty about the literature conclusions. (http://www.guidelinedevelopment.org/handbook/).
Formulating conclusions
For diagnostic, etiological, prognostic or adverse effect questions, the evidence was summarized in one or more conclusions, and the level of the most relevant evidence was reported. For intervention questions, the conclusion was drawn based on the body of evidence (not one or several articles). The working groups weighed the beneficial and harmful effects of the intervention.
Considerations
Aspects such as expertise of working group members, patient preferences, costs, availability of facilities and organisation of healthcare aspects are important to consider when formulating a recommendation. These aspects were discussed in the paragraph Considerations.
Formulating recommendations
The recommendation answers the clinical question and was based on the available scientific evidence and the most relevant considerations.
Constraints (Organisation of healthcare)
During the development of the outline of the guideline and the rest of the guideline development process, the Organisation of healthcare was explicitly taken into account. Constraints that were relevant for certain clinical questions were discussed in the Consideration paragraphs of those clinical questions. The comprehensive and additional aspects of the Organisation of healthcare were discussed in a separate chapter.
Development of quality indicators
Internal (meant for use by scientific society or its members) quality indicators are developed simultaneously with the guideline. Furthermore, existing indicators on this subject were critically appraised; and the working group produces an advice about such indicators. Additional information on the development of quality indicators is available by contacting the Knowledge Institute for the Federation Medical Specialists. (secretariaat@kennisinstituut.nl).
Knowledge Gaps
During the development of the guideline, a systematic literature search was performed the results of which help to answer the clinical questions. For each clinical question the working group determined if additional scientific research on this subject was desirable. An overview of recommendations for further research is available in the appendix Knowledge Gaps.
Comment- and authorisation phase
The concept guideline was subjected to commentaries by the involved scientific societies. The commentaries were collected and discussed with the working group. The feedback was used to improve the guideline; afterwards the working group made the guideline definitive. The final version of the guideline was offered for authorization to the involved scientific societies and was authorized.
References
Brouwers MC, Kho ME, Browman GP, et al. AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010;182(18):E839-E842.
Medisch Specialistische Richtlijnen 2.0. Adviescommissie Richtlijnen van de Raad Kwalitieit, 2012. Available at: http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html.
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 at: http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.
Schünemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336(7653):1106-10. Erratum published in: BMJ 2008;336(7654).
Ontwikkeling van Medisch Specialistische Richtlijnen: stappenplan. Kennisinstituut van Medisch Specialisten.
Zoekverantwoording
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