Comparison of Two ECG Guided PICC Insertion Techniques

Comparison of Two ECG Guided PICC Insertion Techniques, a Randomized Controlled Trial

The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip.

Study Overview

• Status: Completed
• Conditions: Chemotherapy; Long Term Antibiotics; Total Parenteral Nutrition; Central Venous Access
• Intervention / Treatment: Device: LifeCath-CT PICC easy™ (Vygon); Device: PowerPICC-SOLO® (C.R. Bard)

Detailed Description

One technique uses ECG signal transmission with saline water and allows external catheter length adjustment while the other technique uses a guidewire for signal transmission thus requiring prior catheter length adjustment

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Refusal to be informed in the event of a chance discovery

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: Saline ECG with Pilot Tip Location System; PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water	Device: LifeCath-CT PICC easy™ (Vygon); ECG electrodes are placed on patient's chest ensuring that there is a distinguishable P-wave. Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify a suitable vein. The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique. The PICC is advanced into the central circulation and used as an intracavitary electrode (connection with Vygocard2™). Saline water instilled through the catheter ensures conductivity. The ECG is then used until displayed intracavitary P-wave has a maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction). The PICC hub side is then trimmed and the catheter part connected. The PICC is caped with a neutral bidirectional valve. The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess the position.
Experimental: Guidewire ECG with Sherlock Tip Confirmation System; PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire	Device: PowerPICC-SOLO® (C.R. Bard); ECG electrodes are placed on patients chest ensuring that there is a distinguishable P-wave. Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify suitable vein. The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique. The catheter's free end is cut to the anticipated length using anthropometric measurements (insertion/axillary crease+axillary crease/sternal notch+13cm) and the preloaded magnetic-tipped stylet (serving as intracavitary electrode) is put inside. The PICC is advanced into central veins until intravascular ECG displays a P-wave with maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction). The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance from catheter tip to cavo-atrial junction (CAJ)	At the end of intervention tip position is measured on chest fluoroscopic X-ray. Absolute distance in centimeters from tip to CAJ is measured on the image	At the end of intervention

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 in centimeters	At the end of intervention
Haemostasis time	Haemostasis time at the puncture site entry point (0, 1, 3, 5, >5 minutes)	At the end of intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): August 20, 2021

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Central Venous Catheter; Catheterization; PICC; ECG guidance
• Other Study ID Numbers: 2020-00583

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