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Completed

NCT Number: NCT06594562

Free Fluid Detection With Telementored eFAST

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.

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Key information

Conditions

Hemoperitoneum Ascites Digestive System Diseases Hemorrhage Intra-Abdominal Fluid Collection Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo university hospital, Rikshospitalet

Oslo, 0372, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Telementored eFAST

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Mental effort

    Time frame: Immediately after each telementored eFAST examination

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

  2. User experience

    Time frame: Immediately after each telementored eFAST examination

    Feedback questionnaire adapted from McBeth et al.

  3. 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

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

  4. Learning curve (efficiency)

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

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Telementored eFAST in Patients Post-Liver Surgery: A Study of Diagnostic Accuracy for Detection of Free Fluid

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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