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Clinical Trial NCT06550193 for Augmented Reality, Virtual Reality is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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AR/VR for Ultrasound-guided Medical Procedures 100 Virtual
Clinical Trial NCT06550193 is an interventional study for Augmented Reality, Virtual Reality and is currently not yet recruiting. Enrollment is planned to begin on 1 September 2025 and continue until the study accrues 100 participants. Led by Stanford University, this study is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 12 August 2024.
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 ...Show More
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 ...Show More
Official Title
The Use of Augmented Reality (AR) or Virtual Reality (VR) to Enhance the Precision and Accuracy of Ultrasound-guided Medical Procedures
Conditions
Augmented RealityVirtual RealityOther Study IDs
- 75204
NCT ID Number
Start Date (Actual)
2025-09
Last Update Posted
2024-08-12
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
ultrasound-guided procedure
nerve block
nerve block
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAR/VR AR/VR technology for ultrasound-guided procedures. | 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. |
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- adult patients presenting for ultrasound-guided procedures, with ASA physical status I, II, or III.
- pregnancy
- incarceration
- BMI >35
Study Responsible Party
Jean-Louis Horn, Principal Investigator, Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University
Study Central Contact
Contact: Jean-Louis Horn, MD, 5033811645, [email protected]
Contact: Ksenia (kasimova), MD, 6507889458, [email protected]
1 Study Locations in 1 Countries
California
Stanford University, Stanford, California, 94305, United States
Ksenia Kasimova, MD, Contact, 650-788-9458, [email protected]
Jean Louis-Horn, MD, Principal Investigator