Free Fluid Detection With Telementored eFAST
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Telementored eFAST
Diagnostic testUltrasound examination guided in real-time by a remote expert for detecting free fluid.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Telementored eFASTExperimental treatment 1 intervention
Trial outcomes
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 participant2
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 participant3
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 examinationSecondary 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 examination2
User experience
Feedback questionnaire adapted from McBeth et al.
Time frame
Immediately after each telementored eFAST examination3
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 examination4
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 examinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov