TUFF: Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants

Sponsor
Region Skane (Other)
Overall Status
Recruiting
CT.gov ID
NCT04867460
Collaborator
(none)
375
1
2
9
41.7

Study Details

Study Description

Brief Summary

The study will include patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation. A 1:1 randomization will be performed to either standard access (at the discretion of the surgeon) or ultrasound-guided using a wireless vascular transducer (Siemens Freestyle). Primary outcome is mean time to vascular access. In addition, success rate, complication rate and total procedure time will be measured.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound guided venous access
N/A

Detailed Description

Pacemaker- and defibrillator lead implants typically involve vascular access via the left cephalic, axillar or subclavian vein. Gaining access is usually straight forward for an experienced surgeon/implanter, but can be difficult in a minority of cases, or for implanters with less experience. Complications include arterial puncture, pneumothorax and local bleeding or hematoma. Traditionally cephalic vein cut-down is the first choice, but is only available in 70% of cases, and for more complex procedures involving three electrodes, an additional access is always required.

Ultrasound guidance is very common in other vascular access areas such as femoral artery, radial artery and internal jugular vein, but has not gained widespread acceptance in pacemaker procedures. High quality studies, demonstrating superiority or non-inferiority over other access methods are lacking.

The present study will include all comer patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation. A 1:1 randomization will be performed to either standard access (at the discretion of the surgeon) or ultrasound-guided using a wireless vascular transducer (Siemens Freestyle). Implanters with various degrees of ultrasound experience and pacemaker surgery experience will participate in the study. All implanters will receive a 2-hour training lecture and additional hands-on training for the first 3 cases, by an ultrasound-experienced anaesthesiologist.

Access time and success rate will be recorded, and all acute complications will be recorded. Primary outcome is mean time to vascular access. In addition, success rate, complication rate and total procedure time will be measured. Outcome data will be analyzed for the entire cohort, but also stratified for implanter and excluding the first 10 cases for each implanter, to compensate for various experience and individual learning curve.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
375 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:1 randomization1:1 randomization
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ultrasound-guided Venous Access, Using a Wireless Probe, for Pacemaker and Defibrillator Implants - a Randomized Study
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ultrasound guided venous access

Vascular access of the axillary vein will be performed using an ultrasound system (Siemens Acuson Freestyle) with a wireless vascular ultrasound probe (L8-3 or L13-5). One or more vascular punctures will be performed, as needed.

Procedure: Ultrasound guided venous access
Access of the axillary vein using ultrasound guidance.

No Intervention: Standard of care

Vascular access of the axillary or subclavian vein will be performed using anatomical landmarks, fluoroscopy and/or injection of X-ray contrast in the antecubital vein, at the choice of the implanter. One or more vascular punctures will be performed, as needed.

Outcome Measures

Primary Outcome Measures

  1. Mean time to complete venous access [Peroperatively]

    Time from start of vascular access attempt to achieved access for the required number access points (ie number of leads)

Secondary Outcome Measures

  1. Mean time to first venous access [Peroperatively]

    Time from start of vascular access attempt to achieved access for the first introducer or lead

  2. Successrate for full venous access [Peroperatively]

    Percentage of cases with achieved full venous access using the assigned technique, without having to change technique

  3. Successrate for full venous access within 3 minutes [Peroperatively]

    Percentage of cases with achieved full venous access within 3 minutes, using the assigned technique, without having to change technique

  4. Full venous access without any complication [Peroperatively within 24 hours]

    Percentage of full venous access without any complication (including arterial puncture, pneumothorax, hemothorax, local hematoma and other acute complications)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Planned pacemaker or implantable defibrillator surgery with at least one new transvenously placed lead.
Exclusion Criteria:
  • Difficult vascular access known before surgery, where special access technique is planned or required.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Skane University Hospital Lund Sweden

Sponsors and Collaborators

  • Region Skane

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Region Skane
ClinicalTrials.gov Identifier:
NCT04867460
Other Study ID Numbers:
  • TUFF-study
First Posted:
Apr 30, 2021
Last Update Posted:
Apr 30, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Region Skane
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 30, 2021