HemoperitoneumNCT06594562
Free Fluid Detection With Telementored eFAST
A study testing Telementored eFAST in people with Hemoperitoneum and Ascites, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemoperitoneum, Ascites, Intra-Abdominal Fluid Collection
- What is being tested?
- Telementored eFAST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNorway
- Study dates
- 18 Jun 2025to 16 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone laparoscopic liver surgery at the Oslo university hospital and are within 72 post-surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telementored eFAST in Patients Post-Liver Surgery: A Study of Diagnostic Accuracy for Detection of Free Fluid
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.
- Being tested
- Telementored eFAST
- Keywords
- Teleultrasound, eFAST, Telemedicine, Ultrasound
- Medical subject headings
- Hemoperitoneum, Ascites, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telementored eFASTDiagnostic test
Ultrasound examination guided in real-time by a remote expert for detecting free fluid.
| Study group | Role | What they receive |
|---|---|---|
| Telementored eFAST | Experimental | Ultrasound examination guided in real-time by a remote expert for detecting free fluid, compared to standard ultrasound performed by on-site radiologist. Receives: Diagnostic Test: Telementored eFAST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance rate
Comparison of telementored eFAST vs. CT and expert examination with percentage agreement, Cohen's cappa and Gwet's AC1
Measured: Assessed immediately after each ultrasound examination (telementored and conventional) for each participant
Exam duration
Time measurement from probe contact to mutual agreement between expert and examiner that exam is finished in minutes:seconds
Measured: Within 72 hours of surgery for each participant
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
Measured: Assessed retrospectively at the end of data collection, expected to be within 6 months after the final recorded examination
Secondary outcomes (4)
Mental effort
Cognitive workload during eFAST, measured by NASA Task Load Index on a numerical score (1-9)
Measured: Immediately after each telementored eFAST examination
User experience
Feedback questionnaire adapted from McBeth et al.
Measured: Immediately after each telementored eFAST examination
Learning curve (Mental effort)
Asess improvement in eFAST exam efficiency by comparing mental effort over multiple examinations
Measured: 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
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.
Measured: Assessed cumulatively through study completion, estimated up to 6 months after final participant examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Jun 2025
- Primary completion15 Sep 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoperitoneumStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Brun, Oslo University Hospital
- Investigators
- Henrik Brun, Professor, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594562
- Sponsor's protocol ID
- 172964
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telementored eFAST in Patients Post-Liver Surgery: A Study of Diagnostic Accuracy for Detection of Free Fluid
- ClinicalTrials.gov ID
- NCT06594562
- Acronym / sponsor ID
- 172964
- Keywords
- Teleultrasound, eFAST, Telemedicine, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telementored eFAST | Experimental | Diagnostic Test: Telementored eFASTUltrasound examination guided in real-time by a remote expert for detecting free fluid, compared to standard ultrasound performed by on-site radiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have undergone laparoscopic liver surgery at the Oslo university hospital and are within 72 post-surgery
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telementored eFASTUltrasound examination guided in real-time by a remote expert for detecting free fluid. | Diagnostic test | Telementored eFAST |
Primary outcome
Concordance rate
Time frame: Assessed immediately after each ultrasound examination (telementored and conventional) for each participant
Comparison of telementored eFAST vs. CT and expert examination with percentage agreement, Cohen's cappa and Gwet's AC1
Exam duration
Time frame: Within 72 hours of surgery for each participant
Time measurement from probe contact to mutual agreement between expert and examiner that exam is finished in minutes:seconds
Image quality
Time frame: Assessed retrospectively at the end of data collection, expected to be within 6 months after the final recorded examination
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
4 secondary outcomes
Mental effort
Time frame: Immediately after each telementored eFAST examination
User experience
Time frame: Immediately after each telementored eFAST examination
Learning curve (Mental effort)
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
Learning curve (efficiency)
Time frame: Assessed cumulatively through study completion, estimated up to 6 months after final participant examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Brun, Professor study director
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telementored eFAST in people with Hemoperitoneum and Ascites, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Sep 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance rate (time frame: Assessed immediately after each ultrasound examination (telementored and conventional) for each participant). The study lists 3 primary outcomes in all. 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 30 Sep 2026.