Evaluation of the Ejection Fraction of the Left Ventricle in the Emergency Room by a New Automatic Evaluation Tool in a Pocket Ultrasound Scanner: A Reproducibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- evaluate the interobserver reproducibility
研究概览
简要总结
Clinical ultrasound has become essential in emergency medicine. The guidelines are to use of echocardiography in specific contexts: dyspnea, hypotension or chest pain. The evaluation of left ventricle ejection fraction (LVEF) is one of the basic objectives of echocardiography. The reference assessment in emergency medicine is visual assessment. It suffers from poor inter-observer reproducibility. Pocket ultrasound scanners seem to meet the constraints of point-of-care ultrasound. A new tool is available on a pocket ultrasound device: the automatic evaluation of LVEF. Its interest could be to have a better inter-observer reproducibility than visual evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient over 18 years of age
- •Management in the investigator centre
- •Admitted for dyspnea or hypotension or chest pain
排除标准
- •Age < 18 years
- •Patient not benefiting from a social security system
- •Patient deprived of liberty
- •Patient under the protection of justice, under guardianship or curatorship
- •Patient refusing to participate in the study
- •Inability to provide the patient with informed information
研究组 & 干预措施
Echocardiography
• Echocardiography performed by the evaluator 1: 2 LVEF visual evaluations 2 LVEF automatic evaluations
• Echocardiography performed by the evaluator 2: 2 LVEF visual evaluations 2 LVEF automatic evaluations
干预措施: echocardiography (Procedure)
结局指标
主要结局
evaluate the interobserver reproducibility
时间窗: Day 0
evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device
次要结局
- Evaluate the intraobserver reproducibility of the automatic LVEF measurement(Day 0)
- Interobserver reproducibility of the visual LVEF measurement;(Day 0)
- Assess the interobserver reproducibility of visual LVEF(day 0)
- Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination.(Day 0)
- Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination considering image quality(Day 0)