Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Echocardiography acquisition score [in %] [Operator's outcome]
研究概览
简要总结
This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.
详细描述
The primary objective of this study is to assess the feasibility for non-expert users (medical professionals but non-certified sonographers) to acquire parasternal, apical and subcostal views of suitable quality by using an existing ultrasound device (CE-marked, available in the market) and an additional guidance system (software prototype + probe motion tracking device). Such a system will help the user to place the probe on the patient and provide guidance for optimal acquisition of parasternal, apical and subcostal views.
The secondary objective of this study is to assess the feasibility for non-expert users to reproduce a simple clinical protocol by using an existing ultrasound device and the same additional guidance system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Masking is not applicable, since software study
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All volunteers must have the ability to provide informed consent.
- •All volunteers should be affiliated to the French Social Security.
- •All volunteers will be scheduled for a routine transthoracic echocardiography exam in the echocardiography laboratory at the investigation site as part of standard care.
排除标准
- •Subjects with congenital heart diseases (except bicuspid aortic valve)
- •Pregnant women
- •Adults lacking decisional capacity
- •Adults placed under a legal protection regime (guardianship, curatorship, judicial protection)
- •Adults not affiliated to the French Social Security
- •Adults in emergent or critical condition
- •Adults with active pain in the intended scanning region
- •Adults with active skin disease or lesions in the intended scanning region
- •Adults with allergy/sensitivity to ultrasound gel
结局指标
主要结局
Echocardiography acquisition score [in %] [Operator's outcome]
时间窗: Day 1
Composite measurement that characterizes the echocardiography acquisition of the operator who is being assessed with respect to a 2D reference acquisition The echocardiography acquisition score is a combination of the view type score and the image quality score
Time to acquisition [in seconds] [Operator's performance]
时间窗: Day 1
Time to acquisition \[in seconds\] to reach an echocardiography acquisition score of 25%, 50%, 75% and 90%
Displacement [in mm] of the echocardiography probe with respect to the 2D reference acquisition [Technical reproducibility]
时间窗: Day 1
Displacement \[in mm\] of the echocardiography probe at the acquisition time with respect to the 2D reference acquisition \[Reproducibility of the probe position and orientation\]
Displacement [in mm] of the echocardiography probe with respect to the ideal acquisition [Geometrical reliability]
时间窗: Day 1
Displacement \[in mm\] of the echocardiography probe at the acquisition time with respect to the ideal (geometrical) acquisition estimated from 3D reference acquisition \[Geometrical reliability of the probe position and orientation\]
次要结局
- Left ventricular Ejection Fraction [in %] [Measurement reproducibility](Day 1)