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Recruiting NCT06594562

Free Fluid Detection With Telementored eFAST

No phase Interventional Hemoperitoneum Ascites Intra-Abdominal Fluid Collection Postoperative Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telementored eFAST.
Who it may be relevant to
Registry conditions: Hemoperitoneum, Ascites, Intra-Abdominal Fluid Collection, Postoperative Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Telementored eFAST in Patients Post-Liver Surgery: A Study of Diagnostic Accuracy for Detection of Free Fluid

Overview

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

Primary outcome measures

  • Concordance rate [Time frame: Assessed immediately after each ultrasound examination (telementored and conventional) for each participant]
  • Exam duration [Time frame: Within 72 hours of surgery for each participant]
  • Image quality [Time frame: Assessed retrospectively at the end of data collection, expected to be within 6 months after the final recorded examination]
Secondary outcome measures (4)
  • Mental effort [Time frame: Immediately after each telementored eFAST examination]
  • User experience [Time frame: Immediately after each telementored eFAST examination]
  • Learning curve (Mental effort) [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]
  • Learning curve (efficiency) [Time frame: Assessed cumulatively through study completion, estimated up to 6 months after final participant examination]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Norway · 1 center
  • Oslo university hospital, Rikshospitalet — Oslo

Identifiers

NCT: NCT06594562 · 172964

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗