Feasibility and Accuracy of Focused Cardiac Ultrasound Using an FDA Approved Hand-held Ultrasound Device in Outpatient Setting in Our Institution.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies.
研究概览
简要总结
To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.
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
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to pediatric cardiology clinic at Holtz Children's hospital requiring comprehensive or limited transthoracic echocardiogram.
- •Willing and able to provide informed consent or assent.
- •In clinically stable condition as assessed by the principal investigator..
- •With adequate echocardiographic windows.
排除标准
- •Patients with poor echocardiographic windows.
- •Patients who refuse informed consent.
- •Pregnant women.
- •Prisoners.
- •Patients deemed unfit to participate in the clinical trial as assessed by the principal investigator.
研究组 & 干预措施
treatment group
All participants to receive standard transthoracic echocardiogram and hand held echocardiogram
干预措施: Philips EPIQ 7 ultrasound machine (Device)
treatment group
All participants to receive standard transthoracic echocardiogram and hand held echocardiogram
干预措施: Philips Lumify Broadband sector array transducer (Device)
结局指标
主要结局
Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies.
时间窗: Day 1
Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography
次要结局
未报告次要终点
研究者
Mary Sokoloski
Professor
University of Miami