Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Yu, 2020

Study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCTs

Literature search up to July 2019

A: Baldinelli, 2015

B: Barnwall, 2016

C: Cales, 2016

D: Elli, 2016

E: Gebhard, 2007

F: Lee, 2009

G: Yuan, 2017

H: Liu, 2015

I: Zheng, 2015

Study design: RCT

Setting and Country:

Single center, China

Source of funding and conflicts of interest:

This study was supported by a research grant from the Army Medical

University.

The authors declare no conflicts of interest.

Inclusion criteria SR:

RCTs that investigated the use of ECGs to localize the peripherally inserted central catheter tip position. Eligible studies compared patients in whom the ECG localization technique was used with subsequent chest X-ray to confirm the tip position. Studies were considered eligible for inclusion regardless of publication status, language or size.

Exclusion criteria SR:

(a) were not RCTs, (b) did not compare ECG guidance technology and landmark positioning, (c) were in a language for which a translation to English was not available or (d) were unpublished studies with only the abstracts presented at national and international meetings.

9 studies included

Important patient characteristics at baseline:

Number of patients; characteristics important to the research question and/or for statistical adjustment (confounding in cohort studies); for example, age, sex, bmi, ...

N (ECG/landmark)

A: 42/48

B:  30/30

C: 102/85

D: 75/44

E: 147/143

F: 121/128

G: 499/504

H: 85/85

I: 513/515

Electrocardiogram (ECG) localization technique followed by chest X-ray

A: ECG

B: ECG

C: ECG

D: ECG

E: ECG

F: ECG

G: ECG

H: ECG

I: ECG

Landmark-based insertion followed by chest X-ray

A: landmark

B: landmark

C: landmark

D: landmark

E: landmark

F: landmark

G: landmark

H: landmark

I: landmark

End-point of follow-up:

Not specified

For how many participants were no complete outcome data available?

Not specified

Correct placement

RR [95% CI] of accurate placement

A: 1.24 [1.03, 1.49]

B: 1.74 [1.28, 2.38]

C: 1.13 [0.84, 1.52]

D: 1.26 [1.06, 1.51]

E: 1.27 [1.15, 1.40]

F: 1.00 [0.95, 1.05]

G: 1.18 [1.06, 1.51]

H: 1.13 [1.04, 1.23]

I: 0.99 [0.97, 1.01]

Pooled effect (random effects model): 1.17 [1.04, 1.32]

favoring ECG.

Heterogeneity (I²): 94%

ECG N=1614

Landmark N=1580

Quality of life

Not reported

Patient satisfaction

Not reported

Complications (not specified in review)

RR [95% CI] of complications

A: 0.16 [0.01, 3.06]

B: 0.04 [0.00, 0.60]

C: 0.52 [0.29, 0.93]

D: not reported

E: 0.14 [0.06, 0.34]

F: No events

G: 0.48 [0.35, 0.65]

H: 0.05 [0.00, 0.80]

I: not reported

Pooled effect (random effects model): 0.28 [0.14, 0.55]

favoring ECG.

Heterogeneity (I²): 64%

ECG N=1026

Landmark N=1023

Catheter-related interventions

Not reported

Costs

Not reported

Resource availability

Not reported

Risk of bias (high, some concerns or low):

PEDro scale study quality (0-10)

A: 8

B: 8

C: 7

D: 6

E: 7

F: 7

G: 8

H: 7

I: 6

The overall quality of all studies was fair to good, but the therapists and participants were not blinded in the design of all articles.

Author’s conclusions:

The existing research shows that the application of atrial ECG in PICC tip positioning can improve the accuracy of catheter tip positioning,

reduce the incidence of related complications and provide a scientific basis for further promotion of the atrial ECG positioning method.

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size

Gullo, 2021

Type of study:

RCT

Setting and country:

Single center, Switzerland

Funding and conflicts of interest:

Funding not stated in publication. On clinicaltrials.gov Qanadli is stated as the study sponsor.

S. D. Qanadli is a consultant for C.R. Bard, Inc. The remaining authors declare that they have no disclosures relevant to the subject matter of this article.

Inclusion criteria:

All consecutive patients who were more than 18 years old and had been referred to the radiology department for PICC insertion were considered for study enrollment

Exclusion criteria:

Candidates were excluded if they weighed more than 150 kg (table load limit) or had cardiac arrhythmia affecting the P wave

N total at baseline:

Intervention: 60

Control: 60

Important prognostic factors²:

Age, mean ± SD:

I: 59.8 ± 15.8

C: 60.6 ± 18.3

Sex:

I: 51.7% M

C: 37.9% M

BMI, mean ± SD:

I: 26.0 ± 6.5

C: 25.4 ± 5.7

Left arm access

I: 73.3%

C: 63.8%

Basilic vein access

I: 66.7%

C: 81.0%

Groups were comparable at baseline

Electromagnetic guidance combined with intracavitary ECG tracing (ECG-EM)

Combined ECG-EM guidance was performed using an ultrasound system (Site-Rite 8) with an integrated system for guidance and PICC tip confirmation (Sherlock-3CG Diamond-Tip Confirmation System, BD and Company). Inall patients, we used a 4-French single-lumen or 5-French dual-lumen catheter (PowerPICC2 Solo, C.R. Bard).

The Y-shaped magnetic sensor and external ECG electrodes were placed on the patient to ensure distinct P-wave presence. The procedure was similar to the FX-guided procedure except for PICC length estimation and navigation to CAJ.

the PICC was cut, prepared so that the magnetic tip stylet inserted therein was close to its tip, and advanced into central circulation through a “peel-away” sheath using EM guidance of the integrated system, until reaching the superior vena cava (SVC). The stylet generates a field detected by the Y sensor so that the PICC can be followed in real time on a display. Finally, the ECG was used to drive the catheter into the target position— that is, until the intracavitary P wave increased and reached its maximum height in the absence of negative deflection.

Fluoroscopic guidance (FX)

FX guidance was performed using a multipurpose x-ray system (Artis Zee, Siemens Healthcare).

The FX-guided PICC placement procedure is based on the technique described by Glauser et al.

At the end of the procedure, the final tip position was documented by immediate posteroanterior chest radiography, which was performed with the patient in a supine position during deep inspiration.

Length of follow-up:

End of the PICC placement procedure

Loss-to-follow-up:

N/A

Incomplete outcome data:

N/A

Correct placement

T1 corresponds to a final tip position of less than or equal to 1 cm from the CAJ and is defined as optimal placement; T2, more than 1 cm to less than or equal to 3 cm above or below the CAJ (suboptimal placement); and T3, more than 3 cm under the CAJ or not in the SVC (inadequate placement requiring repositioning).

T3, inadequate placement requiring repositioning

I: 13/60 (21.7%)

C: 0/58 (0%)

T2, suboptimal positioning

I: 21/60 (36.8%)

C: 16/58 (28.1%)

T1, optimal positioning

I: 23/60 (40.4%)

C: 41/58 (71.9%)

Complications

Not reported

Quality of life

Not reported

Patient satisfaction

Not reported

Catheter-related interventions

Not reported

Costs

Not reported

Resource availability

Not reported

Authors’ conclusions

our results showed optimal tip position in 71.9% of FX-guided procedures versus 40.4% of ECG-EM–guided procedures. With our stringent criteria for classifying tip position, 22.8% of the ECG-EM–guided procedures needed further correction, whereas 0% of the FX-guided procedures required reintervention in the FX group. Furthermore, all PICCs requiring additional actions were inserted from the left side. Thus, ECG-EM guidance could not replace FX guidance in unselected patients. However, ECG-EM guidance could be considered as an acceptable technique to replace FX guidance among patients in whom the PICC is inserted from the right side.

Mack, 2020

Type of study:

RCT

Setting and country:

Single center, Germany

Funding and conflicts of interest:

The study was funded with an educational grant from C. R. Bard GmbH, Karlsruhe, Germany (later joined Becton, Dickinson and Company, Franklin Lakes, NJ, USA). The company did neither have any influence on design and conduct of the study nor on collection and reporting of data.

All authors declare that they have no conflict of interest with respect to this article.

Inclusion criteria:

Patients were eligible for inclusion if they were at least 18 years of age and had a medical indication for PICC insertion.

Exclusion criteria:

Exclusion criteria were systemic infection, infection including puncture site, and known allergy to materials used. Additionally, cardiac arrhythmia including atrial fibrillation, severe tachycardia, or paced rhythm was exclusion criterion because it could interfere with interpretation of the P-wave morphology when using the TCS system.

N total at baseline:

Intervention: 105

Control: 105

Important prognostic factors²:

Age, mean ± SD:

I: 60.6 ± 13.8

C: 64.1 ± 13.0

Sex:

I: 67.6% M

C: 60.0% M

BMI, mean ± SD:

I: 26.0 ± 6.5

C: 25.4 ± 5.7

Groups were comparable at baseline.

Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System

(at bedside)

Sherlock 3CG® TCS

(including single-use PowerPICC SOLO catheter with Sherlock 3CG tip positioning system stylet, Becton, Dickinson and Company, Franklin Lakes, NJ, USA) was used for magnetic tracking of the PICC tip and real-time ECG confirmation of the tip position during insertion.

Fluoroscopy

(in the radiology

department)

Length of the guidewire was measured to determine the required PICC length. Subsequently, an introducer sheath was inserted over the wire, the guidewire was removed, and the PICC catheter inserted through the introducer sheath and then advanced under fluoroscopic control to the predetermined length. The same PICC kit type in different sizes was used in all patients.

Finally, in both groups, the PICC was attached on the arm with a seamless stabilization device (StatLockTM, Bard Access Systems, Becton, Dickinson and Company, Franklin Lakes, NJ, USA). Placement of the catheter was confirmed by obtaining chest X-ray.

Length of follow-up:

2 weeks

Loss-to-follow-up:

Access not possible

I: 3

C: 1

No 2-week clinical investigation:

I: 3

C: 1

Incomplete outcome data:

N/A

Correct placement

Correct PICC tip position was defined as within the mid to lower superior vena cava, at the level of the cavoatrial junction, or within the upper portion of the right atrium, corresponding to 1.5 vertebral body units (approximal 3 cm) from the tracheal carina on chest X-ray obtained immediately after insertion.

I: 84/102 (82.4%)

C: 103/104 (99.0%)

Complications

Bleeding event (minor access site bleedings)

I: 8/99 (8.1%)

C: 13/103 (12.6%)

Pain (mild to moderate)

I: 8/99 (8.1%)

C: 12/103 (11.7%)

Allergic reaction (due to antimicrobial film dressing)

I: 0/99 (0%)

C: 3/103 (2.9%)

Local wound infection

I: 2/99 (2.0%)

C: 2/103 (1.9%)

Thrombosis

I: 0/99 (0%)

C: 0/103 (0%)

Nerve damage

I: 0/99 (0%)

C: 0/103 (0%)

Catheter malfunction

I: 0/99 (0%)

C: 0/103 (0%)

Quality of life

Not reported

Patient satisfaction

Not reported

Catheter-related interventions

Not reported

Costs

Not reported

Resource availability

Not reported

Authors’ conclusions

TCS for PICC insertion was associated with less tip position accuracy than fluoroscopy. However, it was associated with reasonable success and a similar complication rate.

For this reason, we conclude that TCS would be most

useful in patients where fluoroscopy cannot be used, bedside placement is necessary, or resources are limited.

Alexandrou, 2022

ACTRN

12620000919910

Type of study:

RCT

Setting and country:

Single center, tertiary referral hospital, Australia

Funding and conflicts of interest:

Unrestricted investigator-initiated research grants form Cook Medical Australia, Flo Medical Australia and CR Bard. All funds were paid to Western Sydney University and not to individual researchers.

The authors declared no conflict of interest.

Inclusion criteria:

Age at least 18 years; native P wave on 12 lead ECG, ability to provide written informed consent in English.

Exclusion criteria:

Pacemaker dependency; <18 years old, no informed consent at time of catheter insertion.

N total at baseline:

Intervention: 172

Control: 172

Important prognostic factors²:

Age, median (IQR):

I: 58 (49-68)

C: 60 (51-69)

Sex:

I: 56% M

C: 60% M

BMI, median (IQR):

I: 28 (24-34)

C: 28 (24-34)

Catheter type

CVC double lumen

I: 0%

C: 1%

CVC triple lumen

I: 4%

C: 3%

Dialysis catheter

I: 5%

C: 5%

PICC single lumen

I: 59%

C: 73%

PICC double lumen

I: 32%

C: 18%

Groups were comparable at baseline.

Intracavitary electrocardiography guided CVAD placement with CXR confirmation

Portable, wireless IC-ECG navigation system (Nautilus Delta Tip Confirmation System – BARD access systems, Salt lake City, USA)

When maximum P-wave amplitude was achieved, the tip was considered in position.

Landmark based CVAD placement with CXR confirmation.

In both groups, CXR was taken immediately after catheter insertion to compare tip position.

Length of follow-up:

Not specified

Loss-to-follow-up:

None

Incomplete outcome data:

None

Catheters not requiring repositioning

as interpreted on CXR: lower third of the SVC (within 3 cm above of tracheal carina), the CAJ (up to 3 cm below tracheal carina) or upper RA (3-5 cm below tracheal carina).

I: 162/172 (94%)

C: 131/172 (76%)

Complications

CLABSI per 1000 catheter days

I: 0/172 (0%)

C: 1/172 (0.2%)

Catheter removal for suspected infection

I: 7/172 (4.1%)

C: 3/172 (1.7%)

Catheter removal for symptomatic thrombosis

I: 2/172 (1.2%)

C: 1/172 (0.6%)

Catheter removal for dislodgement

I: 13/12 (7.6%)

C: 5/172 (2.9%)

Quality of life

Not reported

Patient satisfaction

Not reported

Catheter-related interventions

Not reported

Costs

Total, in Australian dollars

I: 36,546

C: 47,206

Average per patient

I: 212

C: 265

Resource availability

Not reported

Authors’ conclusions

Intracavitary ECG is more accurate and efficient than traditional placement of CVADs and can be used across diverse patient cohorts requiring a wide range of devices.

Jayaraman, 2019

Type of study:

RCT

Setting and country:

Single center, India

Funding and conflicts of interest:

No financial support and sponsorship.

There are no conflicts of interest.

Inclusion criteria:

patients aged between 18 to 65 years requiring central venous catheterization.

Exclusion criteria:

Patients with atrial fibrillation. Multifocal ventricular premature complexes, left bundle branch block, patient with cardiac pacemaker and altered coagulation profile.

N total at baseline:

Intervention: 60

Control: 60

Important prognostic factors²:

Age, mean ± SD:

ECG: 40.8±16.22

Landmark: 39.23±14.69

Formula: 44.9±17.2

Sex (male/female):

ECG:  43/17

Landmark: 48/12

Formula: 41/19

BMI:

ECG: 25.39±4.56 

Landmark: 25.18±3.99

Formula: 25.88±3.75

Groups were comparable at baseline.

Intra-atrial Electrocardiography (ECG) guided technique:

the catheter was slowly advanced until the RA‑ECG indicated a CVC

position in the SVC/RA junction (peaked, tall P‑wave) or in the RA (biphasic P‑wave).[7] Thereafter, the CVC was withdrawn at 0.5 cm intervals until the P‑wave returned to a normal configuration. At that point, the CVC was secured at the skin with suture and dressed with a transparent dressing and the depth of insertion noted. If an intra atrial ECG could not be obtained, the CVC was fixed to a depth of 15 cms.

Landmark technique

the vertical distance between the right clavicular notch and the carina was measured on the routine preprocedure CXR, using an internal measuring tool available on the hospital’s picture archiving communication system. The vertical distance between the insertion point of the puncture needle and the right clavicular notch was measured using a sterile disposable ruler. The final depth of CVC insertion was determined by adding the two measurements.

Peres’ formula method:

In the Formula group, heights of all the patients were measured

prior to the procedure and the catheter was inserted and final insertion depth was kept as per the Peres’ formula of “height (in cm)/10”.

Length of follow-up:

Catheter placement procedure

Loss-to-follow-up:

None

Incomplete outcome data:

None

Proper positioning

CVC tip was properly positioned within 1 cm above and below the carina

ECG: 58/60 (96.7%)

Landmark: 56/60 (93.3%)

Formula: 35/60 (58.3%)

Complications

Not reported

Quality of life

Not reported

Patient satisfaction

Not reported

Catheter-related interventions

Not reported

Costs

Total, in Australian dollars

Not reported

Resource availability

Not reported

Authors’ conclusions

We conclude that both landmark guidance and ECG guidance are comparable with regard to accurate central venous catheter tip positioning when CVCs are placed through right internal

jugular vein whereas formula based technique is least

accurate and results in overinsertion of CVCs.

Yin, 2019

Yin, 2020

ChiCTR

1900022763

Type of study:

RCT

Setting and country:

Multicenter, China

Funding and conflicts of interest:

This work was supported by the Innovation and Achievement Transformation Fund of Shandong Province (No. 2013ZHZX2A0401).

Hai-Jun Zhang holds intellectual property rights on the technology licensed to Branded Tech Inc., who manufactured the PICCs described in the paper. Zhang guarantees the impartiality during implementation. Other authors have no conflict of interest.

Inclusion criteria:

(a) clinical indication to PICC insertion, (b) age between 18 and 80 years, and (c) normal P-wave appearance on the surface ECG recordings.

Exclusion criteria:

pregnancy, previous history of central line insertion, cardiovascular conditions such as valve heart disease, atrial fibrillation, supraventricular tachycardia, pulmonary heart disease, pacemaker implantation, and history of cardiac surgery, which may affect P-waves.

N total at baseline:

Intervention: 1500

Control: 750

Important prognostic factors²:

Age, mean ± SD:

I: 55.1 ± 10.9

C: 58.1 ± 10.5

Sex:

I: 57.9% F

C: 57.2%

Puncture site

Upper left arm

I: 47.5%

C: 44.8%

Upper right arm

I: 39.4%

C: 41.3%

Basilic vein:

I: 87.8%

C: 86.1%

Groups were comparable at baseline.

Intracavitary electrocardiogram (IC-ECG) guidance

Tip-conductive PICC was advanced gently until 5 cm was remaining, after which IC-ECG was performed according to the standard technique. As the catheter

was slowly advanced into the SVC, the P-wave gradually increased, reaching a maximal peak at the CAJ. As the catheter entered the RA, a diphasic P-wave appeared and

the catheter was retracted slowly to return to the position of maximal peak P-wave, with no negative components.

Traditional anatomical landmarks method was used to estimate the catheter length.

Length of follow-up:

6 months

Loss-to-follow-up:

Intervention: 6 patients (0.4%) with no P-wave changes were excluded

Control: 0

Incomplete outcome data:

None

Unsatisfactory location by X-ray

The position of the tip close to the CAJ (approximately 3 cm below the tracheal carina) was considered optimal

I: 11/1500 (0.7%)

C: 99/750 (13.2%)

Complications

At 1 week

Exit site infection

I: 3/750 (0.2%)

C: 4/1494 (0.5%)

RR 2.68 (0.60–11.99)

Phlebitis

I: 0%

C: 0%

DVT

I: 0%

C: 0%

Catheter malposition

I: 2 (0.1%)

C: 1 (0.1%)

RR 1.00 (0.09–11.05)

At 6 months

Exit site infection

I: 40 (2.7%)

C: 30 (4.0%)

RR 1.52 (0.94–2.46)

Phlebitis

I: 16 (1.1%)

C: 10 (1.3%)

RR 1.25 (0.57–2.78)

DVT

I: 18 (1.2%)

C: 11 (1.5%)

RR 1.23 (0.58–2.61)

Catheter malposition

I: 15 (1.0%)

C: 12 (1.6%)

RR 1.61 (0.75–3.46)

Catheter breakage

I: 3 (0.2%)

C: 2 (0.3%)

Extravasation

I: 36 (2.4%)

C: 22 (2.9%)

Total complications

I: 96/1494 (6.4%)

C: 71/750 (9.5%)

Quality of life

Not reported

Patient satisfaction

Not reported

Catheter-related interventions

Not reported

Costs

Total, in Australian dollars

Not reported

Resource availability

Not reported

Authors’ conclusions

our study demonstrated that the intra-procedural tip location by IC-ECG is safer and more accurate than the traditional method of verifying tip location only post-procedurally, by chest X-ray. It can achieve a rapid and accurate tip location during

PICC placement, reduce the need of reposition, the whole time of procedure and X-ray exposures, especially

decrease the PICC-related complications.

Glauser, 2016

Type of study:

RCT

Setting and country:

Single center, Switzerland

Funding and conflicts of interest:

The scientific guarantor of this publication is

Salah Dine Qanadli. The authors of this manuscript declare relationships

with the following companies: Salah Dine Qanadli was a consultant for C.

R Bard Inc. during the last 3 years. The authors state that this work has not received any funding. No complex statistical methods were necessary for

this paper.

Inclusion criteria:

all consecutive patients >18 years referred to the interventional radiology department for PICC insertion.

Exclusion criteria:

Patients were excluded if they were unable

or refused to consent to participate.

N total at baseline:

Intervention: 90

Control: 90

Important prognostic factors:

Age, mean ± SD:

I: 61.8 ± 1.8

C: 60.7 ± 1.9

Sex:

I: 51% M

C: 49% M

Groups were comparable at baseline.

Fluoroscopy guided insertion.

The final CTP was documented with an immediate chest fluoroscopy (posteroanterior projection) with the patient’s arm in adduction and the patient in deep inspiration.

All PICCs were done in the Interventional Radiology Unit using a low-dose X-ray system and US guidance with a 5 to 10-MHz linear-array transducer. All procedures were performed by an interventional radiology team

experienced in PICC placement (10 years’ experience, with

>800 procedures per year). Operators (SB, FG) were

instructed to use a standardized procedure. All operators received specific BST training prior to the study. The PowerPICC2® Solo (4-F single lumen or 5-F dual lumen)

device was used for all participants.

Bedside insertion with postprocedural X-ray.

Once the insertion site was identified, we estimated catheter length using two cutaneous anatomic landmarks: the right

clavicular head and the third intercostal space. The distance was measured between planned insertion sites to the right

clavicular head, then down to the third intercostal space, with the shoulder abducted to 90°, as previously described.

Once the insertion site was identified, we estimated catheter length using two cutaneous anatomic landmarks: the right

clavicular head and the third intercostal space. The distance was measured between planned insertion sites to the right

clavicular head, then down to the third intercostal space, with the shoulder abducted to 90°, as previously described.

Length of follow-up:

Insertion and following X-ray.

Loss-to-follow-up:

none

Reintervention

- Type 1: optimal tip position located either more than or

less than 1 cm from the CAJ

– Type 2: suboptimal tip location not requiring repositioning, with tip located >1 cm under the CAJ or >1 cm

above the CAJ but remaining in the SVC

– Type 3: nonoptimal tip location requiring repositioning, with tip located >3 cm under the CAJ or not inside the SVC

Type 3:

I: 1/89 (1%)

C: 27/90 (30%)

Complications

I: 8/89 (9%)

C: 6/90 (6.7%)

Cost-effectiveness

Not reported

Authors’ conclusions:

This study clearly demonstrates that techniques used for placement are not equal for attaining optimal CTP. Considering the importance of the CTP, the FGT should be considered at least for patients at high risk of complications. Further evaluations are needed to better select patients for the optimal placement technique, and technologica

advances will aid in greater CTP accuracy when using the the BST.

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 blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were 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

Gullo, 2021

Probably yes;

Reason: Randomization was performed with 1:1 allocation using sequentially numbered opaque sealed envelopes

Definitely yes;

Reason: opaque sealed envelopes

Definitely yes;

Reason: final chest radiographs were anonymized, and tip positions were assessed in terms of navigation and localization success independently by radiologists and radiologic technicians, all of whom are members of the PICC team and were blinded to guiding technique. Blinding of patients was not reported.

Probably yes;

Reason: Loss to follow-up was infrequent in intervention and control group. Adequate imputation methods (multiple imputation) were used.

Definitely yes;

Reason: All relevant outcomes were reported

Probably yes;

Reason: Some concerns about the role of the study sponsor. However, the results do not seem to be in favor of the sponsor.

LOW

Mack, 2020

Definitely yes;

Reason: Eligible patients were allocated 1:1 to either TCS or fluoroscopy by means of computer-generated randomization.

No information

Definitely no

Reason: Open-label trial

Definitely yes

Reason: Loss to follow-up was infrequent in intervention and control group.

Probably yes

Reason: All relevant outcomes were reported.

Probably yes;

Reason: No other problems noted.

LOW

The reported outcomes are likely not affected by lack of blinding

Alexandrou, 2022

Definitely yes;

Reason: random allocations were computer generated in a 1:1 ratio using R

Definitely yes;

Reason: random allocations were concealed to investigators and patients until enrolment.

Definitely no

Reason: Pragmatic, open-label trial

Definitely yes;

Reason: there was no loss to follow up.

Probably yes

Reason: All relevant outcomes were reported.

Probably yes;

Reason: No other problems noted.

LOW

The reported outcomes are likely not affected by lack of blinding

Jayaraman, 2019

No information

No information

Definitely yes;

Reason: CXRs were

read by one attending radiologist, who was aware of the study

protocol but blinded to the group assignment.

Definitely yes;

Reason: there was no loss to follow up.

Probably yes

Reason: All relevant outcomes were reported.

Probably yes;

Reason: No other problems noted.

SOME CONCERNS

due to lack of information about randomization and allocation concealment

Yin, 2019

Yin, 2020

Definitely yes;

Reason: Patients were randomly assigned to either the study group or to the control group in a 2:1 allocation. A

site-stratified block randomization with randomly varying

block sizes of 4 and 6 was performed.

Definitely yes;

Reason: Random assignment was performed by a statistician from Fudan University, and random envelopes were assigned to each site. Sequences were concealed from patients and clinical staff until assignment.

Definitely no;

Reason: Open label study.

Definitely yes;

Reason: there was no loss to follow up.

Probably yes

Reason: All relevant outcomes were reported.

Probably yes;

Reason: No other problems noted.

LOW

The reported outcomes are likely not affected by lack of blinding

Glauser, 2016

Definitely yes;

Patients were randomly assigned in a 1:1 manner to the BST or the FGT using sequentially numbered, opaque, sealed

envelopes.

Definitely yes;

Patients were randomly assigned in a 1:1 manner to the BST or the FGT using sequentially numbered, opaque, sealed

envelopes.

Definitely yes;

Chest X-rays were  interpreted by senior interventional radiologists (SC, SDQ) blinded to the technique used for catheter insertion.

Definitely yes;

Reason: there was no loss to follow up.

Probably yes;

Reason: All relevant outcomes were reported.

Probably no;

Reason: The criteria for repositioning used in the study did not exactly match the criteria as proposed by the guideline development group.

SOME CONCERNS

for the outcome repositioning

Reference

Reason for exclusion

Ling G, Zhiwen W, Guorong W, Shaomei S, Xue W. Guide wire electrode versus liquid electrode for intravascular electrocardiography-guided central venous catheterization in adults: A systematic review and meta-analysis. J Vasc Access. 2020 Sep;21(5):564-572. doi: 10.1177/1129729819868044. Epub 2019 Aug 17. PMID: 31422729.

wrong comparison

Liu G, Hou W, Zhou C, Yin Y, Lu S, Duan C, Li M, Toft ES, Zhang H. Meta-analysis of intracavitary electrocardiogram guidance for peripherally inserted central catheter placement. J Vasc Access. 2019 Nov;20(6):577-582. doi: 10.1177/1129729819826028. Epub 2019 Mar 6. PMID: 30838913.

more recent meta-analysis used

Practice Guidelines for Central Venous Access 2020: An Updated Report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2020 Jan;132(1):8-43. doi: 10.1097/ALN.0000000000002864. PMID: 31821240.

wrong study design

Chu KS, Hsu JH, Wang SS, Tang CS, Cheng KI, Wang CK, Wu JR. Accurate central venous port-A catheter placement: intravenous electrocardiography and surface landmark techniques compared by using transesophageal echocardiography. Anesth Analg. 2004 Apr;98(4):910-914. doi: 10.1213/01.ANE.0000105865.94157.4C. PMID: 15041571.

wrong comparison

Dong H, Zhu Y, Zhang X, Yin X, Liu F. Chest CT tomography vs. intracavitary electrocardiogram guidance in predicting the length of PICC placement. BMC Surg. 2022 May 19;22(1):197. doi: 10.1186/s12893-022-01604-0. PMID: 35590297; PMCID: PMC9118803.

wrong comparison

Xu YF, Xu XF, Song K, Qiu C, Zhang XL, Mam DL, Huang S. Study on the Safety and Accuracy of Intracavitary Electrocardiography and Ultrasound in the Peripherally Inserted Central Venous Catheter tip positioning of Breast Cancer Patients. INDIAN JOURNAL OF PHARMACEUTICAL SCIENCES. 2021 Jan 1;83:6-11.

wrong comparison

Li A, Jiao J, Zhang Y, Tian L, Miao J, Hao X, Sun Z, Sun Q. A randomized controlled study of bedside electrocardiograph-guided tip location technique & the traditional chest radiography tip location technique for peripherally inserted central venous catheter in cancer patients. Indian J Med Res. 2018 May;147(5):477-483. doi: 10.4103/ijmr.IJMR_1120_16. PMID: 30082572; PMCID: PMC6094514.

Control group not sufficiently defined

Yuan L, Li R, Meng A, Feng Y, Wu X, Yang Y, Chen P, Qiu Z, Qi J, Chen C, Wei J, Qin M, Kong W, Chen X, Xu W. Superior success rate of intracavitary electrocardiogram guidance for peripherally inserted central catheter placement in patients with cancer: A randomized open-label controlled multicenter study. PLoS One. 2017 Mar 9;12(3):e0171630. doi: 10.1371/journal.pone.0171630. PMID: 28278167; PMCID: PMC5344315.

Data extracted from meta-analysis

Cales YK, Rheingans J, Steves J, Moretti M, PICC Team. Electrocardiogram-guided peripherally inserted central catheter tip confirmation using a standard electrocardiogram machine and a wide-mouth electrocardiogram clip compared with traditional chest radiograph. Journal of the Association for Vascular Access. 2016 Mar 1;21(1):44-54.

Data extracted from meta-analysis

Sharma D, Singh VP, Malhotra MK, Gupta K. Optimum depth of central venous catheter - Comparision by pere's, landmark and endocavitory (atrial) ECG technique: A prospective study. Anesth Essays Res. 2013 May-Aug;7(2):216-20. doi: 10.4103/0259-1162.118966. PMID: 25885836; PMCID: PMC4173511.

wrong study design

Lee JH, Bahk JH, Ryu HG, Jung CW, Jeon Y. Comparison of the bedside central venous catheter placement techniques: landmark vs electrocardiogram guidance. Br J Anaesth. 2009 May;102(5):662-6. doi: 10.1093/bja/aep046. Epub 2009 Mar 26. PMID: 19329467.

Data extracted from meta-analysis

Gebhard RE, Szmuk P, Pivalizza EG, Melnikov V, Vogt C, Warters RD. The accuracy of electrocardiogram-controlled central line placement. Anesth Analg. 2007 Jan;104(1):65-70. doi: 10.1213/01.ane.0000250224.02440.fe. PMID: 17179244.

Data extracted from meta-analysis