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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Procedure success rate (Primary Block) [Срок оценки: 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 [Срок оценки: 12 hours after surgery]
• Post-operative pain scores [Срок оценки: 12 hours after surgery]

Вторичные конечные точки (4)

• Clinician satisfaction [Срок оценки: Within 24 hours of block completion]
• Procedure duration [Срок оценки: During the procedure]
• Needle pass/redirection [Срок оценки: During the procedure]
• Needle visualisation [Срок оценки: Within 24 hours of block completion]

Критерии участия

Критерии включения

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

Критерии исключения

• pregnancy
• incarceration
• BMI >35

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Stanford Hospital and Clinics — Stanford

Идентификаторы

NCT: NCT06550193 · 75204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗