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Clinical CompetenceRemote-eFASTNCT07686497

Remote Guidance for eFAST Training Using a Head-Mounted Device

A study testing Standardized instructional eFAST video, Real-time audio remote expert guidance (Microsoft Teams) and Head-mounted-device remote expert guidance (Arc 3, RealWear) in people with Clinical Competence and Ultrasonography, run by Philipp Fürnstahl at 1 site in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Standardized instructional eFAST video, Real-time audio remote expert guidance (Microsoft Teams) and Head-mounted-device remote expert guidance (Arc 3, RealWear)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSwitzerland
Study dates
17 Aug 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site
  • Balgrist Campus, University Hospital Balgrist

    Zurich, Canton of Zurich, 8008

    Nicola Cavalcanti, MD, +41 44 510 7000

Other trials in Switzerland

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Standardized instructional eFAST video, Real-time audio remote expert guidance (Microsoft Teams), Head-mounted-device remote expert guidance (Arc 3, RealWear)
Keywords
eFAST, POCUS, point-of-care ultrasound, tele-ultrasound, remote guidance, head-mounted device, simulation training, medical education, QUICk, OSAUS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardized instructional eFAST videoBehavioural

    Also called eFAST training 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.

  • Real-time audio remote expert guidance (Microsoft Teams)Behavioural

    Also called Audio-only tele-mentoring

    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.

  • Head-mounted-device remote expert guidance (Arc 3, RealWear)Device

    Also called HMD tele-mentoring; Arc 3 head-mounted device

    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.

Study groups in NCT07686497
Study groupRoleWhat they receive
Video-onlyActive comparatorinstructional eFAST video only; no live remote guidance
Receives: Behavioral: Standardized instructional eFAST video
Video+audioExperimentalInstructional video plus real-time audio-only remote guidance via Microsoft Teams; the expert sees the live ultrasound image
Receives: Behavioral: Standardized instructional eFAST video; Behavioral: Real-time audio remote expert guidance (Microsoft Teams)
Video+HMDExperimentalInstructional 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
Receives: Behavioral: Standardized instructional eFAST video; Device: Head-mounted-device remote expert guidance (Arc 3, RealWear)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. eFAST image-quality score (QUICk Global Rating Scale, GRS)

    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

    Measured: Three examinations during the study session (Day 1); blinded scoring during the rating period (up to ~3 months after)

Secondary outcomes (10)
  1. eFAST image quality, QUICk Task-Specific Checklist (TSC)

    Participant-level mean QUICk Task-Specific Checklist score across the three eFAST examinations. The TSC has 28 image-based items, each scored 1 (performed adequately) or 0, covering the four abdominal and cardiac windows and the right and left lung separately; total 0 to 28. Each examination is scored by two blinded experts who did not supervise it. Minimum 0, maximum 28; higher scores indicate better image quality.

    Unit of Measure: score on a 0 to 28 scale

    Measured: Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)

  2. eFAST operator competence, Adapted OSAUS

    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

    Measured: Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)

  3. Global diagnostic adequacy rating

    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

    Measured: Day 1 examinations; blinded scoring during the rating period (up to ~3 months after the session)

  4. Mean eFAST examination duration

    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

    Measured: Day 1 (study session)

  5. Perceived workload (NASA-TLX, raw)

    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

    Measured: Day 1, immediately after the session

  6. System usability (System Usability Scale, SUS)

    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

    Measured: Day 1, immediately after the session

  7. Headset comfort and tolerability

    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

    Measured: Day 1, immediately after the session

  8. Perceived guidance quality (participant-rated)

    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

    Measured: Day 1, immediately after the session

  9. Expert-rated feasibility and communication quality

    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

    Measured: Day 1, after each guided session

  10. Expert-rated technical reliability

    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

    Measured: Day 1, after each guided session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start17 Aug 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07686497
Sponsor's protocol ID
B-2025-00211
Other IDs
BASEC 2026-00074
Acronym
Remote-eFAST
Status last verified
Aug 2026
First submitted
11 Jun 2026
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. Study data are pseudonymized, access-restricted, and retained for 20 years in accordance with the protocol.

Questions about this trial

What is this clinical trial studying?

A study testing Standardized instructional eFAST video, Real-time audio remote expert guidance (Microsoft Teams) and Head-mounted-device remote expert guidance (Arc 3, RealWear) in people with Clinical Competence and Ultrasonography, run by Philipp Fürnstahl at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicola Cavalcanti, MD (+41 44 510 73 60, Nicola.Cavalcanti@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

eFAST image-quality score (QUICk Global Rating Scale, GRS) (time frame: Three examinations during the study session (Day 1); blinded scoring during the rating period (up to ~3 months after)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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