Free Fluid Detection With Telementored eFAST

NCT06594562 | Recruiting DMC

• 1 other identifier: 172964
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Teleultrasound; eFAST; Telemedicine; Ultrasound

Outcome Measures

Primary Outcomes (3)

• Concordance rate

  Comparison of telementored eFAST vs. CT and expert examination with percentage agreement

  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

  Within 72 hours of surgery for each participant

• Image quality

  An independent radiologist will assess the image quality using a 1-5 Likert scale based on a feedback questionnaire adapted from Mazur et al

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

Secondary Outcomes (4)

• Mental effort

  Immediately after each telementored eFAST examination

• User experience

  Immediately after each telementored eFAST examination

• Learning curve (Mental effort)

  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)

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

Study Arms (1)

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.

Diagnostic Test: Telementored eFAST

Interventions

Telementored eFAST DIAGNOSTIC_TEST

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

Telementored eFAST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo university hospital, Rikshospitalet

Oslo, Oslo County, 0372, Norway

RECRUITING

MeSH Terms

Conditions

Hemoperitoneum; Ascites; Postoperative Complications

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrik Brun, Professor

  Oslo University Hospital

  STUDY DIRECTOR

Central Study Contacts

Peder C Engelsen, MD

CONTACT

+47 417 34 374; peder_engelsen@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The quality of the teleultrasound images will be assessed by a radiologist who did not participate in the telementoring session, to minimize novelty bias. Additionally, the radiologist conducting the direct examinations will be distinct from the remote expert who provided telementoring, ensuring that they do not rely on prior knowledge from the remote sessions. While no formal masking will be implemented, these measures are taken to reduce potential bias in the assessment process.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical researcher

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 19, 2024
• Study Start: June 18, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

NO (1)