Comparison of Two ECG Guided PICC Insertion Techniques

Not Applicable

Completed

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

• Registration Number: NCT04466332
• Lead Sponsor: University of Lausanne

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-10
• Study Start: 2020-09-01
• Primary Completion: 2020-09-01
• Study Completion: 2021-08-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline ECG with Pilot Tip Location System	LifeCath-CT PICC easy™ (Vygon)	PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water
Guidewire ECG with Sherlock Tip Confirmation System	PowerPICC-SOLO® (C.R. Bard)	PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire

Primary Outcome Measures

Name	Time	Method
Distance from catheter tip to cavo-atrial junction (CAJ)	At the end of intervention	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

Secondary Outcome Measures

Name	Time	Method
Haemostasis time	At the end of intervention	Haemostasis time at the puncture site entry point (0, 1, 3, 5, \>5 minutes)
Length of the outgoing catheter	At the end of intervention	Length of the outgoing catheter at the entry point near the bend of the elbow in centimeters

Trial Locations

Locations (1)

CHUV; 🇨🇭 Lausanne, Vaud, Switzerland