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Comparison of Two ECG Guided PICC Insertion Techniques

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ClinicalTrials.gov Identifier: NCT04466332
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Salah D. Qanadli, 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.

Condition or disease Intervention/treatment Phase
Central Venous Access Long Term Antibiotics Chemotherapy Total Parenteral Nutrition Device: LifeCath-CT PICC easy™ (Vygon) Device: PowerPICC-SOLO® (C.R. Bard) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Two ECG Guided PICC Insertion Techniques, a Randomized Controlled Trial
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

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.





Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466332


Contacts
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Contact: Salah Dine Qanadli, Prof. MD PhD +41213144560 salah.qanadli@chuv.ch
Contact: Giuseppe Gullo, MSc +41213144444 giuseppe.gullo@chuv.ch

Locations
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Switzerland
CHUV Recruiting
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne
Centre Hospitalier Universitaire Vaudois
Investigators
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Study Director: Salah Dine Qanadli, Prof. MD PhD UNIL-CHUV
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Responsible Party: Salah D. Qanadli, Professor MD PhD, University of Lausanne
ClinicalTrials.gov Identifier: NCT04466332    
Other Study ID Numbers: 2020-00583
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salah D. Qanadli, University of Lausanne:
PICC
ECG guidance
Central Venous Catheter
Catheterization