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Comparison of Two ECG Guided PICC Insertion Techniques

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ClinicalTrials.gov Identifier: NCT04466332
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Salah D. Qanadli, University of Lausanne

Tracking Information
First Submitted Date  ICMJE July 7, 2020
First Posted Date  ICMJE July 10, 2020
Last Update Posted Date July 22, 2020
Estimated Study Start Date  ICMJE August 1, 2020
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
Distance from catether tip to CAJ (Cavo-atrial junction) [ 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
  • 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
  • Haemostasis time [ Time Frame: At the end of intervention ]
    Haemostasis time at the puncture site entry point (0, 1, 3, 5, >5 minutes)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two ECG Guided PICC Insertion Techniques
Official Title  ICMJE Comparison of Two ECG Guided PICC Insertion Techniques, a Randomized Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Central Venous Access
  • Long Term Antibiotics
  • Chemotherapy
  • Total Parenteral Nutrition
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • 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
    Intervention: Device: LifeCath-CT PICC easy™ (Vygon)
  • 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
    Intervention: Device: PowerPICC-SOLO® (C.R. Bard)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2020)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Salah Dine Qanadli, Prof. MD PhD +41213144560 salah.qanadli@chuv.ch
Contact: Giuseppe Gullo, MSc +41213144444 giuseppe.gullo@chuv.ch
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04466332
Other Study ID Numbers  ICMJE 2020-00583
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Salah D. Qanadli, University of Lausanne
Study Sponsor  ICMJE University of Lausanne
Collaborators  ICMJE Centre Hospitalier Universitaire Vaudois
Investigators  ICMJE
Study Director: Salah Dine Qanadli, Prof. MD PhD UNIL-CHUV
PRS Account University of Lausanne
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP