NCT07686497

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jul 2026Jun 2027

First Submitted

Initial submission to the registry

June 11, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 11, 2026

Last Update Submit

June 29, 2026

Conditions

Keywords

eFASTPOCUSpoint-of-care ultrasoundtele-ultrasoundremote guidancehead-mounted devicesimulation trainingmedical educationQUICkOSAUS

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (10)

  • 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)

  • 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

  • +5 more secondary outcomes

Other Outcomes (5)

  • Learning effect on image-quality score (exam 1 to 3)

    Across the three examinations on Day 1

  • Learning effect on examination duration (exam 1 to 3)

    Across the three examinations on Day 1

  • Time spent per eFAST region/window

    Day 1 (study session)

  • +2 more other outcomes

Study Arms (3)

Video-only

ACTIVE COMPARATOR

instructional eFAST video only; no live remote guidance

Behavioral: Standardized instructional eFAST video

Video+audio

EXPERIMENTAL

Instructional video plus real-time audio-only remote guidance via Microsoft Teams; the expert sees the live ultrasound image

Behavioral: Standardized instructional eFAST videoBehavioral: Real-time audio remote expert guidance (Microsoft Teams)

Video+HMD

EXPERIMENTAL

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

Behavioral: Standardized instructional eFAST videoDevice: Head-mounted-device remote expert guidance (Arc 3, RealWear)

Interventions

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.

Also known as: eFAST training video
Video+HMDVideo+audioVideo-only

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.

Also known as: Audio-only tele-mentoring
Video+audio

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.

Also known as: HMD tele-mentoring; Arc 3 head-mounted device
Video+HMD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist Campus, University Hospital Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

Location

Study Officials

  • Philipp Fürnstahl, PhD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcomes Assessor). Open-label conduct; QUICk/OSAUS raters are blinded and never rate exams they supervised.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Sc. Philipp Fürnstahl, University Hospital Balgrist, Zurich

Study Record Dates

First Submitted

June 11, 2026

First Posted

July 7, 2026

Study Start

July 1, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations