- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07208071
- Original Trial
Investigating the Utility of Augmented Reality Assistance for Ultrasound-Guided Vascular Access
March 9, 2026 updated by: Jeffrey Coote, University of Alabama at Birmingham
Application of Augmented Reality for Point of Care Ultrasound-Guided Procedures
This study will investigate the benefits of augmented reality assistance on ultrasound-guided vascular access.
Using the Microsoft HoloLens 2 headset, the investigators will study the benefits of augmented reality technology as a tool for improving the success rate, efficiency, and ease of access for peripheral venous catheters, peripherally inserted central venous catheters, and central venous catheters.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
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 Contact
- Name: Jeffrey Coote Principal Investigator, MD
- Phone Number: 5044817903
- Email: jdcoote@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Jeffrey D Coote, MD
- Phone Number: 5044817903
- Email: jdcoote@uabmc.edu
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient requiring ultrasound-guided vascular access
Exclusion Criteria:
- Age less than 5 years old
- Need for urgent vascular access
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: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Arm
Providers will not use augmented reality assistance when performing ultrasound-guided vascular access for this arm of the study
|
|
|
Experimental: AR Arm
Providers will use augmented reality assistance when obtaining ultrasound-guided vascular access
|
Use of a Microsoft HoloLens 2 headset with augmented reality assistance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Successful vascular access as indicated by blood return from the blood vessel and advancement of guide wire
Time Frame: Up to 30 minutes
|
Up to 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of needle sticks required for successful vascular access
Time Frame: Up to 30 minutes
|
Up to 30 minutes
|
|
Time required for successful vascular access
Time Frame: Up to 30 minutes
|
Up to 30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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)
January 30, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
September 19, 2025
First Submitted That Met QC Criteria
September 26, 2025
First Posted (Actual)
October 6, 2025
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 9, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- IRB-300014090
- UAB (Other Identifier: UAB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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