Vascular AccessNCT07208071
Investigating the Utility of Augmented Reality Assistance for Ultrasound-Guided Vascular Access
A study testing Augmented reality headset use in people with Vascular Access, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Vascular Access
- What is being tested?
- Augmented reality headset use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient requiring ultrasound-guided vascular access
Who cannot join
- Age less than 5 years old
- Need for urgent vascular access
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: 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.
- Conditions
- Vascular Access
- Being tested
- Augmented reality headset use
- Keywords
- Augmented reality, ultrasound-guided vascular access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented reality headset useOther
Use of a Microsoft HoloLens 2 headset with augmented reality assistance
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Augmented reality headset use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful vascular access as indicated by blood return from the blood vessel and advancement of guide wire
Measured: Up to 30 minutes
Secondary outcomes (2)
Number of needle sticks required for successful vascular access
Measured: Up to 30 minutes
Time required for successful vascular access
Measured: Up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start30 Jan 2026
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular AccessStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Coote, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208071
- Sponsor's protocol ID
- IRB-300014090
- Other IDs
- UAB
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37573178
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Augmented Reality for Point of Care Ultrasound-Guided Procedures
- ClinicalTrials.gov ID
- NCT07208071
- Acronym / sponsor ID
- IRB-300014090
- Conditions
- Vascular Access
- Keywords
- Augmented reality, ultrasound-guided vascular access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Augmented reality headset useProviders will use augmented reality assistance when obtaining ultrasound-guided vascular access |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient requiring ultrasound-guided vascular access
Key exclusion criteria (2 listed)
- Age less than 5 years old
- Need for urgent vascular access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented reality headset useUse of a Microsoft HoloLens 2 headset with augmented reality assistance | Other | AR Arm |
Primary outcome
Successful vascular access as indicated by blood return from the blood vessel and advancement of guide wire
Time frame: Up to 30 minutes
2 secondary outcomes
Number of needle sticks required for successful vascular access
Time frame: Up to 30 minutes
Time required for successful vascular access
Time frame: Up to 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Results publication: PubMed 37573178Saruwatari 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented reality headset use in people with Vascular Access, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful vascular access as indicated by blood return from the blood vessel and advancement of guide wire (time frame: Up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07208071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.