NCT07208071

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

September 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

September 19, 2025

Last Update Submit

March 9, 2026

Conditions

Keywords

Augmented realityultrasound-guided vascular access

Outcome Measures

Primary Outcomes (1)

  • Successful vascular access as indicated by blood return from the blood vessel and advancement of guide wire

    Up to 30 minutes

Secondary Outcomes (2)

  • Number of needle sticks required for successful vascular access

    Up to 30 minutes

  • Time required for successful vascular access

    Up to 30 minutes

Study Arms (2)

Control Arm

NO INTERVENTION

Providers will not use augmented reality assistance when performing ultrasound-guided vascular access for this arm of the study

AR Arm

EXPERIMENTAL

Providers will use augmented reality assistance when obtaining ultrasound-guided vascular access

Other: Augmented reality headset use

Interventions

Use of a Microsoft HoloLens 2 headset with augmented reality assistance

AR Arm

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient requiring ultrasound-guided vascular access

You may not qualify if:

  • Age less than 5 years old
  • Need for urgent vascular access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Related Publications (1)

  • Saruwatari MS, Nguyen TN, Talari HF, Matisoff AJ, Sharma KV, Donoho KG, Basu S, Dwivedi P, Bost JE, Shekhar R. Assessing the Effect of Augmented Reality on Procedural Outcomes During Ultrasound-Guided Vascular Access. Ultrasound Med Biol. 2023 Nov;49(11):2346-2353. doi: 10.1016/j.ultrasmedbio.2023.07.011. Epub 2023 Aug 11.

Central Study Contacts

Jeffrey Coote Principal Investigator, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Critical Care Fellow

Study Record Dates

First Submitted

September 19, 2025

First Posted

October 6, 2025

Study Start

January 30, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations