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

The Use of Augmented Reality (AR) or Virtual Reality (VR) to Enhance the Precision and Accuracy of 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.

Study Overview

• Status: Recruiting
• Conditions: Virtual Reality; Augmented Reality
• Intervention / Treatment: Device: Ultrasound-guided procedure using AR/VR technology

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Louis Horn, MD; Phone Number: 5033811645; Email: hornj@stanford.edu
• Study Contact Backup: Name: Ksenia (kasimova), MD; Phone Number: 6507889458; Email: kasimova@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Hospital and Clinics
      • Contact: Ksenia Kasimova, MD; Phone Number: 6507889458; Email: kasimova@stanford.edu
      • Principal Investigator: Jean Louis-Horn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy
• incarceration
• BMI >35

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR/VR; AR/VR technology for ultrasound-guided procedures.	Device: Ultrasound-guided procedure using AR/VR technology; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure success rate (Primary Block)	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	Document the block result pre-operatively (at least 30 min following block completion), or within one hour upon arriving to PACU
Post-operative opioid consumption	Morphine milligram equivalents (MME) will be measured post-operatively	12 hours after surgery
Post-operative pain scores	Trend pain scores on 11-point NRS scale (from 0 to 10) following the procedure	12 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician satisfaction	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.	Within 24 hours of block completion
Procedure duration	Time of procedure from initial needle insertion to needle removal will be calculated	During the procedure
Needle pass/redirection	The number of times a clinician must remove the needle from the patient completely and reattempt will be calculated.	During the procedure
Needle visualisation	A subjective score will be assessed on a short survey to clinicians.	Within 24 hours of block completion

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: nerve block; ultrasound-guided procedure
• Other Study ID Numbers: 75204

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