Clinical trial NCT06550193: AR/VR for Ultrasound-guided Medical Procedures
Official title: The Use of Augmented Reality (AR) or Virtual Reality (VR) to Enhance the Precision and Accuracy of Ultrasound-guided Medical Procedures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Augmented Reality
Virtual Reality
Keywords: ultrasound-guided procedure
nerve block
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the intervention, which involves utilizing AR/VR technology during ultrasound-guided procedures.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* pregnancy
* incarceration
* BMI \>35

Primary outcomes:
measure: Procedure success rate (Primary Block)
timeFrame: Document the block result pre-operatively (at least 30 min following block completion), or within one hour upon arriving to PACU
measure: Post-operative opioid consumption
timeFrame: 12 hours after surgery
measure: Post-operative pain scores
timeFrame: 12 hours after surgery
Secondary outcomes:
measure: Clinician satisfaction
timeFrame: Within 24 hours of block completion
measure: Procedure duration
timeFrame: During the procedure
measure: Needle pass/redirection
timeFrame: During the procedure
measure: Needle visualisation
timeFrame: Within 24 hours of block completion
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References: