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CompletedNCT06594562Updated Sep 30, 2026

Free Fluid Detection With Telementored eFAST

An interventional study of Telementored eFAST in Hemoperitoneum, Ascites and Intra-Abdominal Fluid Collection, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Diagnostic

Updated Sep 30, 2026Primary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This feasibility study will evaluate the accuracy of telementored eFAST (Extended Focused Assessment with Sonography in Trauma) in detecting abdominal free fluid in patients who have recently undergone liver surgery. The primary goal is to determine how well the remote-guided ultrasound can identify fluid accumulation compared to conventional ultrasound performed by a radiologist. Participants in this study will be examined with ultrasound, supported in real-time by a remote expert, to assess its accuracy and other relevant performance metrics.

Read the detailed description

The study is designed as a prospective diagnostic trial and involves 40 patients at Oslo University Hospital.

Participants will receive an ultrasound examination shortly after surgery, where a nurse is guided in real-time by a remote expert via teleultrasound. The primary objective is to assess the agreement between the telementored eFAST examination and a conventional ultrasound performed by an on-site radiologist. In addition to diagnostic accuracy, the study will evaluate various performance metrics, including the duration of the telementored versus conventional examinations, network reliability, and cognitive workload using the NASA Task Load Index.

The study will also explore the learning curve associated with telementored eFAST by monitoring the improvement in examination efficiency over time. These metrics will help determine the feasibility of using telementored ultrasound as a reliable diagnostic tool in postoperative care, potentially reducing the need for more resource-intensive imaging modalities and improving patient outcomes through timely decision-making.

02

Conditions studied

  • Hemoperitoneum
  • Ascites
  • Intra-Abdominal Fluid Collection
  • Postoperative Complications

Keywords

  • Teleultrasound
  • eFAST
  • Telemedicine
  • Ultrasound
03

In context

Ascites

252 studies on the registry are indexed under Ascites; 52 are open to participants now.

This study's enrollment of 34 is below the median of 55 across 177 interventional studies indexed under Ascites.

Browse Ascites studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients who have undergone laparoscopic liver surgery at the Oslo university hospital and are within 72 post-surgery

Exclusion criteria

Exclusion Criteria:

Allergy to ultrasound gel. Patients colonized with ESBL, MRSA and VRE will be excluded due to infection control. Significant postoperative pain that can exacerbated by probe pressure.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Telementored eFAST

    Ultrasound examination guided in real-time by a remote expert for detecting free fluid, compared to standard ultrasound performed by on-site radiologist.

    Diagnostic Test: Telementored eFAST

Interventions

  • Diagnostic testTelementored eFAST

    Ultrasound examination guided in real-time by a remote expert for detecting free fluid.

06

What researchers measure

Primary outcomes

  1. Concordance rate

    Comparison of telementored eFAST vs. CT and expert examination with percentage agreement, Cohen's cappa and Gwet's AC1

    Time frame: Assessed immediately after each ultrasound examination (telementored and conventional) for each participant

  2. Exam duration

    Time measurement from probe contact to mutual agreement between expert and examiner that exam is finished in minutes:seconds

    Time frame: Within 72 hours of surgery for each participant

  3. Image quality

    The radiologist providing remote guidance will assess the image quality using a 1-5 Likert scale based on a feedback questionnaire adapted from Mazur et al

    Time frame: Assessed retrospectively at the end of data collection, expected to be within 6 months after the final recorded examination

Secondary outcomes

  1. Mental effort

    Cognitive workload during eFAST, measured by NASA Task Load Index on a numerical score (1-9)

    Time frame: Immediately after each telementored eFAST examination

  2. User experience

    Feedback questionnaire adapted from McBeth et al.

    Time frame: Immediately after each telementored eFAST examination

  3. Learning curve (Mental effort)

    Asess improvement in eFAST exam efficiency by comparing mental effort over multiple examinations

    Time frame: Data will be evaluated cumulatively at the end of the study, through study completion, estimated to be up to 6 months after the final participant's examination

  4. Learning curve (efficiency)

    Evaluate whether telementored examiners show changes in eFAST examination duration over time. The duration of each examination will be compared to previous ones for the same examiner to identify trends in efficiency across multiple sessions.

    Time frame: Assessed cumulatively through study completion, estimated up to 6 months after final participant examination

07

Study locations

1 site
  • Oslo university hospital, Rikshospitalet
    Oslo, Oslo 0372, Norway
08

References and documents

Study documents

  • Statistical analysis plan · May 3, 2026

Documents are hosted by the registry — open the source record to download them.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Sep 16, 2026→Sep 15, 2026
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Primary completion Sep 16, 2026→Sep 15, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06594562
Lead sponsor
Oslo University Hospital
Responsible party
Henrik Brun (Clinical researcher, Oslo University Hospital) — Principal investigator
First posted
Sep 19, 2024
Start date
Jun 18, 2025
Primary completion
Sep 15, 2026
Completion
Sep 16, 2026
Last update
Sep 30, 2026

Study contacts

Henrik Brun, Professor
study director · Oslo University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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