Free Fluid Detection With Telementored eFAST

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-18

Study Completion Date

2026-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemoperitoneum Ascites Intra-Abdominal Fluid Collection Postoperative Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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Telementored eFAST

Ultrasound examination guided in real-time by a remote expert for detecting free fluid, compared to standard ultrasound performed by on-site radiologist.

Group Type EXPERIMENTAL

Telementored eFAST

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Telementored eFAST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No