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NCT Number: NCT06550193

Augmented Reality/Virtual Reality (AR/VR) for Ultrasound-guided Medical Procedures

The study seeks to assess the efficacy of incorporating augmented reality (AR) or virtual reality (VR) technology into ultrasound-guided medical procedures such as regional anesthesia and line placement. By utilizing AR/VR devices, the investigators will improve the ergonomics when using ultrasound to guide procedures. The aims are to enhance visualization of anatomical structures and improve procedural accuracy for clinicians. The study aims to evaluate the feasibility, and effectiveness of integrating AR/VR technology into ultrasound-guided procedures, with the ultimate goal of improving patient outcomes.

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Key information

Conditions

Augmented Reality Virtual Reality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Jean Louis-Horn, MD

PRINCIPAL_INVESTIGATOR

Ksenia Kasimova, MD

CONTACT

[email protected]

6507889458

About this study

The investigators aim to learn several key insights from this study. Firstly, they hope to determine the extent to which augmented reality (AR) or virtual reality (VR) technology can enhance the precision and accuracy of ultrasound-guided medical procedures, such as regional anesthesia and line placement. This includes evaluating whether AR/VR visualization leads to improved needle placement and reduced complication rates.

Furthermore, the investigators aim to evaluate the usability and acceptance of AR/VR technology among clinicians, considering factors such as user experience, comfort, and integration with existing workflow processes.

The importance of this new knowledge lies in its potential to improve medical practice by leveraging cutting-edge technology to improve patient outcomes and expand access to quality healthcare globally. If AR/VR proves to be effective in enhancing procedural accuracy, it could lead to significant advancements in healthcare delivery, particularly in underserved communities and resource-limited settings by leveraging remote care. Additionally, insights gained from this study could inform the development of future AI assisted AR/VR applications in medicine, driving innovation and improving the standard of care across various medical specialties.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients presenting for ultrasound-guided procedures, with ASA physical status I, II, or III.

Exclusion criteria

  • pregnancy
  • incarceration
  • BMI >35

Treatment and study plan

Ultrasound-guided procedure using AR/VR technology

Device

Participants will receive the intervention, which involves utilizing AR/VR technology during ultrasound-guided procedures (e.g., regional anesthesia, line placement). All participants will receive standard pre- and post-block or line care as they normally would for the ultrasound-guided procedure.

Primary outcomes

  1. Procedure success rate (Primary Block)

    Time frame: Document the block result pre-operatively (at least 30 min following block completion), or within one hour upon arriving to PACU

    Document the block result in pre-op, if feasible, or PACU by testing sensory (cold spray) and motor function on all nerves covered by the block

  2. Post-operative opioid consumption

    Time frame: 12 hours after surgery

    Morphine milligram equivalents (MME) will be measured post-operatively

  3. Post-operative pain scores

    Time frame: 12 hours after surgery

    Trend pain scores on 11-point NRS scale (from 0 to 10) following the procedure

Secondary outcomes

  1. Clinician satisfaction

    Time frame: Within 24 hours of block completion

    A short survey will be utilized to gather data on clinicians' perceptions of the ease of use, effectiveness, and overall experience with AR/VR tools compared to traditional methods.

  2. Procedure duration

    Time frame: During the procedure

    Time of procedure from initial needle insertion to needle removal will be calculated

  3. Needle pass/redirection

    Time frame: During the procedure

    The number of times a clinician must remove the needle from the patient completely and reattempt will be calculated.

  4. Needle visualisation

    Time frame: Within 24 hours of block completion

    A subjective score will be assessed on a short survey to clinicians.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Louis Horn, MD

CONTACT

[email protected]

5033811645

Ksenia (kasimova), MD

CONTACT

[email protected]

6507889458

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

The Use of Augmented Reality (AR) or Virtual Reality (VR) to Enhance the Precision and Accuracy of Ultrasound-guided Medical Procedures

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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