AR/VR for Ultrasound-guided Medical Procedures

NCT06550193 | Not Yet Recruiting

• 1 other identifier: 75204
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Augmented Reality; Virtual Reality

Keywords

ultrasound-guided procedure; nerve block

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Clinician satisfaction

  Within 24 hours of block completion

• Procedure duration

  During the procedure

• Needle pass/redirection

  During the procedure

• Needle visualisation

  Within 24 hours of block completion

Study Arms (1)

AR/VR

EXPERIMENTAL

AR/VR technology for ultrasound-guided procedures.

Device: Ultrasound-guided procedure using AR/VR technology

Interventions

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.

AR/VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnancy
• incarceration
• BMI \>35

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Central Study Contacts

Jean-Louis Horn, MD

CONTACT

5033811645; hornj@stanford.edu

Ksenia (kasimova), MD

CONTACT

6507889458; kasimova@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine

Model Details: All participants will receive the intervention, which involves utilizing AR/VR technology during ultrasound-guided procedures.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 12, 2024
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)