Ultrasound Axillary Vein Access: Evaluation of Learning Curve for an Alternative Approach to Cardiac Device Implantation

September 30, 2021 updated by: Seth Sheldon, University of Kansas Medical Center
The purpose of this study is to determine the learning curve associated with Ultrasound (US) guided axillary vein access for cardiac device implantation based on length of procedure among operators of various levels of experience and to assess the 30-day complication rate for patients undergoing US guided device placement versus traditional implant methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ultrasound (US) guided axillary vein access for device implantation is an uncommon approach to gain venous access for cardiac device implantation - an extremely common procedure. However, there has been a growing trend of utilizing this approach to obtain venous access for device implantation among operators. Axillary vein access was described back as far as 1997, when it was utilized for contrast guided venipuncture to access the axillary vein for device implantation. Literature has suggested that an axillary venous approach, with either a superficial landmark or radiographic contrast, has better long-term efficacy and lower lead complications than a conventional subclavian approach for patients that had permanent pacemaker implantation. There are a variety of ways to access the axillary vein including contrast venography to help localization, "blind puncture" (utilizing fluoroscopy to identify anatomical landmarks), and US. More recently, operators have begun to utilize US guidance for axillary vein access. Esmaiel has described that US guidance for axillary vein access could potentially improve the success rate of venous access and limit complications. Others, albeit few, have reported US guided access for cardiac device implantation has the ability to reduce complications, is faster to complete, and easier to learn. According to the Agency for Healthcare Research and Quality in the United States, US guided central venous catheter placement is one of the 11 patient safety practices that have the strongest evidence supporting its use in improving patient outcomes. Evidence supports US guidance being standard of care in central venous catheter placement and using US for axillary access as helpful in cardiac device implantation, but providers still utilize predominantly alternative approaches to obtain venous access via the subclavian vein, cephalic cutdown, extrathoracic axillary using fluoroscopy and thoracic axillary using fluoroscopy.

Currently, there is limited data describing outcomes, the efficiency of US guided axillary access for cardiac device implantation, and the learning curve associated with this technique. Data suggests that utilizing the US approach can improve outcomes, be more efficient, and be easier to learn. Investigators recently reported a high success (95%) and low complication rate with US guided axillary access in 187 patients. Despite this limited data, operators still largely use alternative approaches for venous access. In part, this may be due to the learning curve associated with US axillary venous access.

While there is data demonstrating the utility of US guided axillary access, there is little evidence showing the learning curve for operators associated with this technique. The aim of this project is to assess the learning curve of this technique among operators of various levels of experience.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sign written Informed Consent Form.
  • ≥18 years of age up to 90 years old.
  • Eligible and referred for cardiac device implantation.
  • BMI < 35.

Exclusion Criteria:

  • Unable to sign consent.
  • Patient eligible for cardiac device upgrades/ extractions, subcutaneous implantable cardioverter defibrillators (SICD) & leadless devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: US Guided Axillary venous access
Physician/ provider will perform 2 unassisted & 10 solo Ultrasound (US) guided venous access and pocket creation cardiac device implant. First 2 device implant will be done to educate physicians about ultrasound guided venous access. Subsequent subject will be randomized to 2:1 in ultrasound vs. conventional technique.
Procedure: Ultrasound guided venous access
Each physician/ provider will perform 2 assisted ultrasound (US) guided venous access and pocket creation for cardiac device implant and 10 solo ultrasound guided cardiac device implant.
Active Comparator: Conventional technique
Physician/ provider will perform 5 cardiac device implant using conventional technique for venous access and pocket creation.
Procedure: Conventional technique
Physician will perform 5 cardiac device implant using conventional technique of venous access and pocket creation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous access time between US guided and conventional technique
Time Frame: During procedure
Assess changes in venous access and pocket creation time with progressive experience with US guided axillary venous access (learning curve).
During procedure
Time spent for pocket creation between US guided venous access technique and conventional technique.
Time Frame: During procedure
Compare the pocket creation time with US guided axillary venous access versus conventional techniques.
During procedure
Time spent to obtain venous access & pocket creation between experienced and inexperienced physicians.
Time Frame: During procedure
Compare venous access and pocket creation time amongst experienced and inexperienced physicians.
During procedure
To assess 30 day post procedure complications
Time Frame: 30 Day post procedure
Assess 30-day complications between techniques.
30 Day post procedure
Assess acute procedural success between two techniques.
Time Frame: During procedure
Compare overall procedural success whether device was successfully placed or not post procedure between US guided axillary venous access & conventional technique. Success as Assigned- whether implant technique assigned was successful or whether had to switch to an alternative technique.
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Seth Sheldon, MD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2020

Primary Completion (Actual)

June 6, 2021

Study Completion (Actual)

June 6, 2021

Study Registration Dates

First Submitted

May 3, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

October 4, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00145717

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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