NCT Number: NCT06594562
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Oslo, 0372, Norway
Location status: Recruiting
Anselm Schulz, PhD
SUB_INVESTIGATOR
Fridtjof Heyerdahl, MD
SUB_INVESTIGATOR
Henrik Brun, MD, PhD
CONTACT
Mehdi Akhavi, MD
SUB_INVESTIGATOR
Peder Engelsen, MD
CONTACT
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.
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.
Ultrasound examination guided in real-time by a remote expert for detecting free fluid.
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
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
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
Time frame: Immediately after each telementored eFAST examination
Cognitive workload during eFAST, measured by NASA Task Load Index on a numerical score (1-9)
Time frame: Immediately after each telementored eFAST examination
Feedback questionnaire adapted from McBeth et al.
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
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.
Contact information is provided by the study sponsor or research team.
Oslo University Hospital
Other
Telementored eFAST in Patients Post-Liver Surgery: A Study of Diagnostic Accuracy for Detection of Free Fluid
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