Clinical trial NCT06594562: Free Fluid Detection with Telementored EFAST
Official title: Telementored EFAST in Patients Post-Liver Surgery: a Study of Diagnostic Accuracy for Detection of Free Fluid
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemoperitoneum
Ascites
Intra-Abdominal Fluid Collection
Postoperative Complications
Keywords: Teleultrasound
eFAST
Telemedicine
Ultrasound
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concordance rate
timeFrame: Assessed immediately after each ultrasound examination (telementored and conventional) for each participant
measure: Exam duration
timeFrame: Within 72 hours of surgery for each participant
measure: Image quality
timeFrame: Assessed retrospectively at the end of data collection, expected to be within 6 months after the final recorded examination
Secondary outcomes:
measure: Mental effort
timeFrame: Immediately after each telementored eFAST examination
measure: User experience
timeFrame: Immediately after each telementored eFAST examination
measure: Learning curve (Mental effort)
timeFrame: 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
measure: Learning curve (efficiency)
timeFrame: Assessed cumulatively through study completion, estimated up to 6 months after final participant examination
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university hospital, Rikshospitalet
Study officials:
References: