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NCT Number: NCT04466332

Comparison of Two ECG Guided PICC Insertion Techniques

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.

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Key information

Conditions

Central Venous Access Chemotherapy Hyperphagia Long Term Antibiotics Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Total Parenteral Nutrition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Distance from catheter tip to cavo-atrial junction (CAJ)

    Time frame: 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 outcomes

  1. Length of the outgoing catheter

    Time frame: At the end of intervention

    Length of the outgoing catheter at the entry point near the bend of the elbow in centimeters

  2. Haemostasis time

    Time frame: At the end of intervention

    Haemostasis time at the puncture site entry point (0, 1, 3, 5, >5 minutes)

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Collaborators

  • Centre Hospitalier Universitaire Vaudois

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 10, 2020
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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