Free Fluid Detection With Telementored eFAST

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Concordance rate [Срок оценки: Assessed immediately after each ultrasound examination (telementored and conventional) for each participant]
• Exam duration [Срок оценки: Within 72 hours of surgery for each participant]
• Image quality [Срок оценки: Assessed retrospectively at the end of data collection, expected to be within 6 months after the final recorded examination]

Вторичные конечные точки (4)

• Mental effort [Срок оценки: Immediately after each telementored eFAST examination]
• User experience [Срок оценки: Immediately after each telementored eFAST examination]
• Learning curve (Mental effort) [Срок оценки: 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) [Срок оценки: Assessed cumulatively through study completion, estimated up to 6 months after final participant examination]

Критерии участия

Критерии включения

Patients who have undergone laparoscopic liver surgery at the Oslo university hospital and are within 72 post-surgery

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Норвегия · 1 центр

• Oslo university hospital, Rikshospitalet — Oslo

Идентификаторы

NCT: NCT06594562 · 172964

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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