Reliability of Artificial Intelligence (AI)-Augmented Point-of-care Cardiac Ultrasound (POCCUS) in the Hands of Internists
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Degree of agreement
研究概览
简要总结
The study aim is to test the diagnostic performance of internists interpreting echo images aided by the AISAP CARDIO V0.7 diagnostic support system. Ground truth will be established by an interpretation by cardiologists specialized in echo, of the same POCUS images (acquired by the internist \ sonographer ).
Up to 1000 subjects; Study population will be distributed according to the following schema:
Group 1 -up to 800 patients hospitalized in the Internal Medicine division Group 2 - up to 200 patients hospitalized in the acute Geriatric division
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically indicated POCUS cardiac assessment as determined by the treating physicians for an accepted clinical indication
- •Willing and able to provide consent for a short partial transthoracic POCCUS examinations
- •No urgent or other compelling need for a comprehensive echo exam by the echo lab.
排除标准
- •Unstable clinical condition that does not permit any reasonable delay necessary to obtain consent and perform the POCCUS
- •Severe thoracic deformation or thoracic wall infection or wound that does not permit an adequate echocardiographic examination
- •Very poor or non-diagnostic echocardiographic imaging quality on prior echocardiography examinations.
- •Patients after lung resection
- •Patients unable lie in bed and undergo a standard echo study
- •Participation in an interventional study
结局指标
主要结局
Degree of agreement
时间窗: 30 days
Agreement between the internists AI-aided interpretation and the interpretation by expert cardiologist
Clinical significant findings detected by the internist utilizing AI-aided POCUS
时间窗: 30 days
次要结局
- Percent of POCUS images of good quality(30 days)
- Loops that AI interpreted(30 days)