Comparison of Two ECG Guided PICC Insertion Techniques

NCT04466332 | Completed DMC

• 1 other identifier: 2020-00583
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Venous Access; Long Term Antibiotics; Chemotherapy; Total Parenteral Nutrition

Keywords

PICC; ECG guidance; Central Venous Catheter; Catheterization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of the outgoing catheter

  At the end of intervention

• Haemostasis time

  At the end of intervention

Study Arms (2)

Saline ECG with Pilot Tip Location System

EXPERIMENTAL

PICC insertion using electrocardiographic guidance Pilot Tip Location System (TLS), ECG signal transmission is with saline water

Device: LifeCath-CT PICC easy™ (Vygon)

Guidewire ECG with Sherlock Tip Confirmation System

EXPERIMENTAL

PICC insertion using electrocardiographic guidance Sherlock 3CG Tip Confirmation System (TCS), ECG signal transmission is with guidewire

Device: PowerPICC-SOLO® (C.R. Bard)

Interventions

LifeCath-CT PICC easy™ (Vygon) DEVICE

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.

Saline ECG with Pilot Tip Location System

PowerPICC-SOLO® (C.R. Bard) DEVICE

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.

Guidewire ECG with Sherlock Tip Confirmation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne: lead
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Salah Dine Qanadli, Prof. MD PhD

  UNIL-CHUV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD PhD

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: August 20, 2021
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)