FX vs. ECG Guidance for PICC Insertion

Appropriateness of Replacing Fluoroscopic Guidance by ECG Guidance in PICC Insertion, RCT

The aim of this study is to compare two techniques of placing a peripherally inserted central venous catheter (PICC). The first technique, uses ECG based electromagnetic guidance (ECG-EM). The second (reference technique), is guided by X-ray (fluoroscopy).

Study Overview

• Status: Completed
• Conditions: Chemotherapy; Long Term Antibiotics; Total Parenteral Nutrition
• Intervention / Treatment: Device: ECG-EM Guidance; Device: FX Guidance

Detailed Description

The method of placement under fluoroscopic control (FX) is considered as the reference technique. This is often criticized for disadvantages such as costs, logistical problems and relative ionizing radiation. Despite this, it is still advised by 75% of PICC providers.

Appeared about ten years ago, a per procedural guiding technique with intracavitary ECG tracking (ECG-EM) presents a better technical success (precision and specificity) than the blind technique, but there is still a lack in comparing this technique to the FX technique.

This prospective randomized controlled study is designed to compare the PICC insertion using ECG-EM guidance to fluoroscopic (FX) guidance in order to define whether a replacement of the FX technique by ECG-EM is appropriate in terms of the final catheter tip position of the PICC as well as length of the outgoing catheter at the entry point.

All included patients gave their written consent and the study is approved by EC.

Participation is open to all adults referred to the radiology department of the CHUV for insertion of a PICC (monocentric).

Recruited patients will be randomly assigned to one of the two arms (FX or ECG-EM).

For both procedures patient position and preparation (MSB, maximal sterile barrier) are standardized and are similar.

FX method consists on a puncture of an arm vein, under the ultrasound control and local anesthesia. Through the point of puncture, a long wire is then introduced and directed to the level of the target zone located in the superior vena cava under fluoroscopy control. The length of the guide inside the vessel is then measured to adjust the length of the PICC necessary for its optimal positioning.

For ECG-EM insertion technique, the vein puncture is done in similar conditions to the FX method. The length of the PICC is estimated prior to its insertion using morphological landmarks. The placement of the PICC is done using SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) (CE marked device; C. R. Bard, Inc.).

At the end of procedure, a chest x-ray is performed to assess the PICC position. Possible per-procedural complications are documented.

After intervention, the patient is transferred back to the ward or sent home in stable conditions.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed Consent as documented by signature (Informed Consent Form)
• Adult > 18 years
• Referred to the interventional radiology department for PICC insertion

Exclusion Criteria:

• Pregnant women
• Known or suspected non-compliance
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons,
• Impairment of the heart rhythm changing the presentation of the P wave (atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm)
• Enrolled in conflicting research study
• Weight> 150 kg, technical limit for the fluoroscopy table
• Impossibility of obtaining informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECG-EM Guidance; PICC insertion using electrocardiographic and electromagnetic guidance [Site~Rite® 8 Ultrasound System with integrated SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS)]	Device: ECG-EM Guidance; ECG-EM method consists on a puncture of an arm vein, under the ultrasound control and local anesthesia. The length of the PICC is estimated prior to its insertion using morphological landmarks. The placement of the PICC is done using SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) [CE marked device, C. R. Bard, Inc.]. At the end of procedure, a chest x-ray is performed to assess the PICC position
Active Comparator: FX Guidance; PICC insertion using fluoroscopic guidance	Device: FX Guidance; FX method consists on a puncture of an arm vein, under the ultrasound control and local anesthesia. Through the point of puncture, a long wire is then introduced and directed to the level of the target zone located in the superior vena cava under fluoroscopy control. The length of the guide inside the vessel is then measured to adjust the length of the PICC necessary for its optimal positioning. At the end of procedure, a chest x-ray is performed to assess the PICC position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tip to CAJ (Cavo-atrial junction)	At the end of intervention tip position is measured on chest fluoroscopic X-ray. Absolute distance from tip to CAJ is measured on the image. This will reflect proportions of optimal tip positions depending on guidance technology. Rationale is that optimal position is mandatory for adequate functioning of PICC as malpositions may result on cardiac rhythm disorders, thrombosis or premature PICC occlusion.	Up to 1 hour, after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of the outgoing catheter	Length of the outgoing catheter at the entry point near the bend of the elbow. The rationale behind is that correct positioning guarantees optimal haemostasis and might prevent secondary displacement	Up to 1 hour, after the procedure
Inter-observer and intra-observer variance	The CAJ to catheter tip distance is based on subjective assessment by one investigator of the X-ray chest. Rationale behind is that in order to evaluate the impact of potential variation due to subjective interpretation interobserver and intraobserver variance will be quantified	Through study completion, an average of 9 month

Collaborators and Investigators

• Sponsor: Salah D. Qanadli
• Collaborators: Centre Hospitalier Universitaire Vaudois
• Investigators: Study Director: Salah Dine Qanadli, Prof. MD PhD, UNIL-CHUV

Publications and helpful links

General Publications

• Gullo G, Colin A, Frossard P, Jouannic AM, Knebel JF, Qanadli SD. Appropriateness of Replacing Fluoroscopic Guidance With ECG-Electromagnetic Guidance for PICC Insertion: A Randomized Controlled Trial. AJR Am J Roentgenol. 2021 Apr;216(4):981-988. doi: 10.2214/AJR.20.23345. Epub 2021 Feb 17.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): November 8, 2018
• Study Completion (Actual): February 20, 2019

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: ECG; PICC; PIC Line
• Other Study ID Numbers: 2018-00907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No