Telementored eFAST in Patients Post-Liver Surgery: A Study of Diagnostic Accuracy for Detection of Free Fluid
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Exam duration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone laparoscopic liver surgery at the Oslo university hospital and are within 72 post-surgery
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Telementored eFAST (Diagnostic Test)
结局指标
主要结局
Exam duration
时间窗: 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
Concordance rate
时间窗: 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
Image quality
时间窗: 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
次要结局
- Mental effort(Immediately after each telementored eFAST examination)
- User experience(Immediately after each telementored eFAST examination)
- 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)
- Learning curve (efficiency)(Assessed cumulatively through study completion, estimated up to 6 months after final participant examination)
研究者
Henrik Brun
Clinical researcher
Oslo University Hospital