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Remote Guidance for eFAST Training Using a Head-Mounted Device (Remote-eFAST)

29. června 2026 aktualizováno: Philipp Fürnstahl

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

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

75

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Švýcarsko
    • Canton of Zurich
      • Zurich, Canton of Zurich, Švýcarsko, 8008
        • Balgrist Campus, University Hospital Balgrist
        • Kontakt:
          • Nicola Cavalcanti, MD
          • Telefonní číslo: +41 44 510 7000

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Video-only
instructional eFAST video only; no live remote guidance
Behaviorální: 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.
Ostatní jména:
  • eFAST training video
Experimentální: Video+audio
Instructional video plus real-time audio-only remote guidance via Microsoft Teams; the expert sees the live ultrasound image
Behaviorální: 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.
Ostatní jména:
  • eFAST training video
Behaviorální: 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.
Ostatní jména:
  • Audio-only tele-mentoring
Experimentální: 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
Behaviorální: 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.
Ostatní jména:
  • eFAST training video
Přístroj: 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.
Ostatní jména:
  • HMD tele-mentoring; Arc 3 head-mounted device

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
eFAST image-quality score (QUICk Global Rating Scale, GRS)
Časové okno: 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
Three examinations during the study session (Day 1); blinded scoring during the rating period (up to ~3 months after)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
eFAST image quality - QUICk Task-Specific Checklist (TSC)
Časové okno: Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)

Participant-level mean QUICk Task-Specific Checklist score across the three eFAST examinations. The TSC has 27 image-based items, each scored 1 (performed adequately) or 0; total 0 to 27. Each examination is scored by two blinded experts who did not supervise it. Minimum 0, maximum 27; higher scores indicate better image quality.

Unit of Measure: score on a 0 to 27 scale
Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)
eFAST operator competence - Adapted OSAUS
Časové okno: Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)

Participant-level mean Adapted OSAUS (Objective Structured Assessment of Ultrasound Skills) across the three examinations. Three domains (image optimization, systematic examination, interpretation/diagnostic value) are each rated 1 (Poor) to 5 (Excellent); total 3 to 15. Each examination is scored by two blinded experts who did not supervise it. Minimum 3, maximum 15; higher scores indicate better operator competence.

Unit of Measure: score on a 3 to 15 scale
Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)
Global diagnostic adequacy rating
Časové okno: Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)

Participant-level mean global diagnostic-adequacy rating across the three examinations, scored by blinded experts on a 0 to 10 scale (a separate Yes/No "diagnostically adequate" judgement is also recorded). Minimum 0, maximum 10; higher scores indicate greater diagnostic adequacy.

Unit of Measure: score on a 0 to 10 scale
Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)
Mean eFAST examination duration
Časové okno: Day 1 (study session)

Participant-level mean examination duration, averaged across the three eFAST examinations, measured from first probe-skin contact to final eFAST interpretation.

Unit of Measure: minutes
Day 1 (study session)
Perceived workload (NASA-TLX, raw)
Časové okno: Day 1, immediately after the session

Participant-reported task workload measured with the raw (unweighted) NASA Task Load Index. Six dimensions (mental demand, physical demand, temporal demand, performance, effort, frustration) are each rated from 1 (Very Low) to 20 (Very High) and reported as the mean (Performance reverse-scored). Minimum 1, maximum 20; higher scores indicate greater workload.

Unit of Measure: score on a 1 to 20 scale
Day 1, immediately after the session
System usability (System Usability Scale, SUS)
Časové okno: Day 1, immediately after the session

Participant-reported usability of the guidance method, measured with the System Usability Scale (ten items each rated 1 to 5, standard SUS scoring to a 0 to 100 total). Minimum 0, maximum 100; higher scores indicate better usability.

Unit of Measure: score on a 0 to 100 scale
Day 1, immediately after the session
Headset comfort and tolerability
Časové okno: Day 1, immediately after the session

Participant-reported comfort and tolerability of the guidance method, assessed with standardized items on a 7-point Likert scale (1 = Not at all, 7 = Extremely), with additional items for the head-mounted-device arm (device comfort, eye strain, interference with probe handling). Minimum 1, maximum 7; the favorable direction is item-specific (e.g., higher comfort is better, higher distraction or fatigue is worse).

Unit of Measure: score on a 1 to 7 scale
Day 1, immediately after the session
Perceived guidance quality (participant-rated)
Časové okno: Day 1, immediately after the session

Participant-reported quality of the guidance, including clarity of the expert's instructions and visual/gestural cues and helpfulness in locating eFAST windows and completing the examination efficiently, on a 7-point Likert scale. Minimum 1, maximum 7; higher scores indicate better perceived guidance.

Unit of Measure: score on a 1 to 7 scale
Day 1, immediately after the session
Expert-rated feasibility and communication quality
Časové okno: Day 1, after each guided session

Mentoring-expert rating, after each guided session, of how easy it was to guide the participant, how effectively the expert could assess the participant's actions from the provided image(s), and the clarity of the ultrasound image stream (for HMD sessions, the usefulness of the operator-view video stream), on a 7-point Likert scale. Minimum 1, maximum 7; higher scores indicate more favorable feasibility and communication.

Unit of Measure: score on a 1 to 7 scale
Day 1, after each guided session
Expert-rated technical reliability
Časové okno: Day 1, after each guided session

Mentoring-expert rating, after each guided session, of session technical reliability (connection stability, audio quality, ultrasound image-stream quality, and latency) on a 7-point Likert scale (minimum 1, maximum 7; higher = better). The frequency of needing to repeat instructions due to technical issues is recorded on a separate 0 to 5 item and summarized descriptively.

Unit of Measure: score on a 1 to 7 scale
Day 1, after each guided session

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Learning effect on image-quality score (exam 1 to 3)
Časové okno: Across the three examinations on Day 1

Exploratory learning effect: change in the participant's QUICk Global Rating Scale score from the first to the third consecutive examination. A larger positive change indicates greater improvement in image quality.

Unit of Measure: QUICk GRS score (4 to 20 scale)
Across the three examinations on Day 1
Learning effect on examination duration (exam 1 to 3)
Časové okno: Across the three examinations on Day 1

Exploratory learning effect: change in examination duration from the first to the third consecutive examination. A larger reduction indicates greater improvement in speed.

Unit of Measure: minutes
Across the three examinations on Day 1
Time spent per eFAST region/window
Časové okno: Day 1 (study session)

Exploratory scanning-workflow metric derived from optical probe tracking: time spent per eFAST region/window.

Unit of Measure: seconds
Day 1 (study session)
Probe dwell time
Časové okno: Day 1 (study session)

Exploratory scanning-workflow metric derived from optical probe tracking: probe dwell time at eFAST windows.

Unit of Measure: seconds
Day 1 (study session)
Probe trajectory path length
Časové okno: Day 1 (study session)

Exploratory scanning-workflow metric derived from optical probe tracking: total probe trajectory path length on the torso.

Unit of Measure: centimeters
Day 1 (study session)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Philipp Fürnstahl

Vyšetřovatelé

  • Vrchní vyšetřovatel: Philipp Fürnstahl, PhD, Balgrist University Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. srpna 2026

Dokončení studie (Odhadovaný)

1. června 2027

Termíny zápisu do studia

První předloženo

11. června 2026

První předloženo, které splnilo kritéria kontroly kvality

29. června 2026

První zveřejněno (Aktuální)

7. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • B-2025-00211
  • BASEC 2026-00074 (Jiný identifikátor: Cantonal Ethics Committee Zurich)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared. Study data are pseudonymized, access-restricted, and retained for 20 years in accordance with the protocol.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

Vzácné nemoci

Drogové intervence

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Sponzor / Spolupracovníci

Místa

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