Remote Guidance for eFAST Training Using a Head-Mounted Device: A Three-Arm Randomized Simulation Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- eFAST image-quality score (QUICk Global Rating Scale, GRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single (Outcomes Assessor). Open-label conduct; QUICk/OSAUS raters are blinded and never rate exams they supervised.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Video-only
instructional eFAST video only; no live remote guidance
干预措施: Standardized instructional eFAST video (Behavioral)
Video+audio
Instructional video plus real-time audio-only remote guidance via Microsoft Teams; the expert sees the live ultrasound image
干预措施: Standardized instructional eFAST video (Behavioral)
Video+audio
Instructional video plus real-time audio-only remote guidance via Microsoft Teams; the expert sees the live ultrasound image
干预措施: Real-time audio remote expert guidance (Microsoft Teams) (Behavioral)
Video+HMD
Instructional video plus real-time remote guidance via the Arc 3 head-mounted device (RealWear) and Microsoft Teams; the expert sees the participant's point-of-view and the live ultrasound image
干预措施: Standardized instructional eFAST video (Behavioral)
Video+HMD
Instructional video plus real-time remote guidance via the Arc 3 head-mounted device (RealWear) and Microsoft Teams; the expert sees the participant's point-of-view and the live ultrasound image
干预措施: Head-mounted-device remote expert guidance (Arc 3, RealWear) (Device)
结局指标
主要结局
eFAST image-quality score (QUICk Global Rating Scale, GRS)
时间窗: Three examinations during the study session (Day 1); blinded scoring during the rating period (up to ~3 months after)
Participant-level mean QUICk Global Rating Scale across the three eFAST examinations. The GRS has four domains (image adjustment, image sweeping, flow of procedure, overall performance), each rated 1 (Poor) to 5 (Excellent); total 4 to 20. Each examination is scored by two blinded experts who did not supervise it. Minimum 4, maximum 20; higher scores indicate better image quality. Unit of Measure: score on a 4 to 20 scale
次要结局
- Global diagnostic adequacy rating(Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session))
- Mean eFAST examination duration(Day 1 (study session))
- Perceived workload (NASA-TLX, raw)(Day 1, immediately after the session)
- System usability (System Usability Scale, SUS)(Day 1, immediately after the session)
- Headset comfort and tolerability(Day 1, immediately after the session)
- Perceived guidance quality (participant-rated)(Day 1, immediately after the session)
- Expert-rated feasibility and communication quality(Day 1, after each guided session)
- Expert-rated technical reliability(Day 1, after each guided session)
- eFAST image quality - QUICk Task-Specific Checklist (TSC)(Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session))
- eFAST operator competence - Adapted OSAUS(Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session))
- eFAST image quality, QUICk Task-Specific Checklist (TSC)(Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session))
- eFAST operator competence, Adapted OSAUS(Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session))
研究者
Philipp Fürnstahl
Prof. Dr. Sc. Philipp Fürnstahl, University Hospital Balgrist, Zurich
Balgrist University Hospital