Ascites, Hemoperitoneum, Intra-Abdominal Fluid Collection, Postoperative Complications
Conditions
Keywords
Teleultrasound, eFAST, Telemedicine, Ultrasound
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.
Interventions
DIAGNOSTIC_TESTTelementored eFAST
Ultrasound examination guided in real-time by a remote expert for detecting free fluid.
Sponsors
Oslo University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance rate | 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 |
| Exam duration | 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 |
| Image quality | 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
| Measure | Time frame | Description |
|---|---|---|
| Mental effort | Immediately after each telementored eFAST examination | Cognitive workload during eFAST, measured by NASA Task Load Index on a numerical score (1-9) |
| User experience | Immediately after each telementored eFAST examination | Feedback questionnaire adapted from McBeth et al. |
| 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 | Asess improvement in eFAST exam efficiency by comparing mental effort over multiple examinations |
| Learning curve (efficiency) | 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. |
Countries
Norway
Contacts
CONTACTPeder C Engelsen, MD
STUDY_DIRECTORHenrik Brun, Professor
Oslo University Hospital
Outcome results
None listed