NCT05631977已完成不适用
Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aisap LTD
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- POCUS QUALITY
研究概览
简要总结
The present study is a preparatory step towards a multi-reader multi case (MRMC) randomized fully crossed study. As POCUS images are frequently not stored and not methodically acquired using a standardized image acquisition protocol this study will collect cardiac POCUS images in a prespecified manner.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 21 or more
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Unstable clinical condition according to PI clinical judgment
- •Presence of prosthetic cardiac valve at any position and any type
- •Pregnancy or lactation
- •Contact isolation due to infections disease
- •Presence of left ventricular assist device (LVAD)
- •Know existence of congenital heart disease
- •Prosthetic cardiac valve, any
- •BMI 40 or greater
- •Clinical conditions that do not permit a POCUS study according to the judgment of the investigators or treating physicians
- •History of lung resection
- •Known poor cardiac US image quality based on prior echo exams
- •Mechanical ventilation, or other situations where the required ultrasound views cannot be adequately obtained
- •Clinical instability or critical subject condition or any condition the study PI judges that the POCUS exam could adversely affect the participant
结局指标
主要结局
POCUS QUALITY
时间窗: 1 month
Primary endpoint: Percent of POCUS exams that attain the pre-specified POCUS image quality threshold (quality standard)
次要结局
- Subgroup analysis(1 month)
研究者
研究点 (3)
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