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Recruiting NCT06550193

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

No phase Interventional Augmented Reality Virtual Reality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound-guided procedure using AR/VR technology.
Who it may be relevant to
Registry conditions: Augmented Reality, Virtual Reality. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
  • Post-operative opioid consumption [Time frame: 12 hours after surgery]
  • Post-operative pain scores [Time frame: 12 hours after surgery]
Secondary outcome measures (4)
  • Clinician satisfaction [Time frame: Within 24 hours of block completion]
  • Procedure duration [Time frame: During the procedure]
  • Needle pass/redirection [Time frame: During the procedure]
  • Needle visualisation [Time frame: Within 24 hours of block completion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Stanford Hospital and Clinics — Stanford

Identifiers

NCT: NCT06550193 · 75204

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗