Clinical trial NCT04867460: Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants
Official title: Ultrasound-guided Venous Access, Using a Wireless Probe, for Pacemaker and Defibrillator Implants - a Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Arrhythmia
Heart Failure
AV Block
Keywords: Pacemaker
Implantable defibrillator
Venous access
Ultrasound
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean time to complete venous access
timeFrame: Peroperatively
Secondary outcomes:
measure: Mean time to first venous access
timeFrame: Peroperatively
measure: Successrate for full venous access
timeFrame: Peroperatively
measure: Successrate for full venous access within 3 minutes
timeFrame: Peroperatively
measure: Full venous access without any complication
timeFrame: Peroperatively within 24 hours
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital
Study officials:
References: