Remote Guidance for eFAST Training Using a Head-Mounted Device

Официальное название

Remote Guidance for eFAST Training Using a Head-Mounted Device: A Three-Arm Randomized Simulation Study

Обзор

This study looks at the best way to remotely teach and guide doctors-in-training to perform a bedside ultrasound exam called eFAST (extended Focused Assessment with Sonography for Trauma), which is used to quickly check injured patients for internal bleeding or air around the lungs. The study takes place in a simulation setting, with no real patients. Resident physicians who have completed the basic ultrasound courses each watch the same short instructional video and then perform three eFAST examinations on the same healthy volunteer. Participants are randomly assigned to one of three groups: (1) the instructional video only, with no live help; (2) the video plus real-time audio guidance from a remote expert who can see the live ultrasound image; or (3) the video plus guidance through a head-mounted device that also lets the expert see the participant's own point of view. Afterwards, experts who were not involved in a given exam review the recorded ultrasound images, without knowing which group the participant was in, and rate the image quality and skill. The study also measures how long the exams take, the participants' workload, and the comfort and usability of the system. The goal is to learn whether real-time remote guidance, and in particular guidance through a head-mounted device, helps trainees produce better and faster eFAST examinations than an instructional video alone.

Подробное описание

Background and rationale: eFAST is a highly operator-dependent skill, and remote (tele-ultrasound) guidance is increasingly used to extend expert support to less-experienced operators. Hands-free head-mounted devices may improve remote mentoring by giving the expert the operator's point of view, but there are no data on their use for eFAST training. This single-center, simulation-based, three-arm randomized controlled study compares three remote-guidance modalities.

Setting and allocation: The study runs in a standardized simulation environment with no patients. Allocation to the three arms is 1:1:1 using permuted blocks with concealed allocation via the REDCap randomization module, with the assigned arm revealed only at the session. After a standardized instructional video and a brief ultrasound-system introduction, each participant performs three consecutive complete eFAST examinations on the same standardized healthy volunteer, under standardized environmental conditions to minimize anatomical and contextual variability.

Technical setup: Examinations use a GE LOGIQ E10s (R4) with an M5Sc-D matrix sector probe. The native ultrasound image is sent over a secure connection to a dedicated study laptop that joins a Microsoft Teams call, so the remote expert sees the live image in real time; in the head-mounted-device arm the participant's point-of-view video is additionally transmitted. Probe motion (optical tracking) and a depth (RGBD) camera are recorded for exploratory workflow analyses, with shared time-stamps used to synchronize the data streams. Live audio is not recorded.

Assessment workflow: The entire scan is recorded continuously; the participant verbally marks each window, and window-specific clips are extracted retrospectively from these time-stamps and pseudonymized. Experts who did not supervise a given examination review the clips while blinded to group allocation, and each scan is reviewed by two independent experts to support an inter-rater reliability estimate. The participating experts also perform on-site benchmark eFAST examinations as a reference.

The study is designed in line with SPIRIT and reported in line with CONSORT 2025.

Вмешательства

• Поведенческое Standardized instructional eFAST video
  All participants watch the same brief standardized instructional eFAST video and receive a short standardized introduction to the ultrasound system, then perform three consecutive complete eFAST examinations on a standardized healthy volunteer. In the video-only arm this is the only instruction; no live expert guidance is provided during the examinations.
• Поведенческое Real-time audio remote expert guidance (Microsoft Teams)
  A remote emergency-ultrasound expert joins the session via Microsoft Teams, views the participant's live ultrasound image in real time (streamed from the GE system to a study laptop that shares it in the call), and provides verbal, audio-only guidance during the eFAST examinations. The expert does not see the participant's point of view. Guidance is real-time only.
• Устройство Head-mounted-device remote expert guidance (Arc 3, RealWear)
  In addition to the live ultrasound image shared via Microsoft Teams, the participant wears the Arc 3 head-mounted device (RealWear), which transmits their point-of-view video to the remote expert in the same Teams call. The expert sees both the point-of-view stream and the live ultrasound image and gives real-time guidance; the participant can see the expert's video on the head-mounted display.

Первичные конечные точки

• eFAST image-quality score (QUICk Global Rating Scale, GRS) [Срок оценки: Three examinations during the study session (Day 1); blinded scoring during the rating period (up to ~3 months after)]

Вторичные конечные точки (10)

• eFAST image quality - QUICk Task-Specific Checklist (TSC) [Срок оценки: Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)]
• eFAST operator competence - Adapted OSAUS [Срок оценки: Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)]
• Global diagnostic adequacy rating [Срок оценки: Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)]
• Mean eFAST examination duration [Срок оценки: Day 1 (study session)]
• Perceived workload (NASA-TLX, raw) [Срок оценки: Day 1, immediately after the session]
• System usability (System Usability Scale, SUS) [Срок оценки: Day 1, immediately after the session]
• Headset comfort and tolerability [Срок оценки: Day 1, immediately after the session]
• Perceived guidance quality (participant-rated) [Срок оценки: Day 1, immediately after the session]
• Expert-rated feasibility and communication quality [Срок оценки: Day 1, after each guided session]
• Expert-rated technical reliability [Срок оценки: Day 1, after each guided session]

Критерии участия

Критерии включения

• Age 18 years or older
• Resident physician currently in postgraduate training
• Completion of the national Basic Course in Abdominal Ultrasound and the Basic Course in Emergency Ultrasound (SGUM)
• Sufficient proficiency in English to understand study instructions, questionnaires, and expert guidance
• Able and willing to attend an approximately 45-minute study session
• Written informed consent

Критерии исключения

• Physical limitations that impair ultrasound performance (e.g., upper-limb injury, uncorrected severe visual impairment)
• Unable to attend the scheduled session
• Participation in conflicting educational studies

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Швейцария · 1 центр

• Balgrist Campus, University Hospital Balgrist — Zurich

Идентификаторы

NCT: NCT07686497 · B-2025-00211 · BASEC 2026-00074

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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