Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume, Cardiac Output, Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 主要终点
- Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume
研究概览
简要总结
Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.
详细描述
Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.
The Cardiac MRI will be received ~1-4 days after the measurement is completed. The data will be compared with data collected from the Necklace and the reference device during the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Must be able to undergo Cardiac MRI
排除标准
- •Sensitivity to electrodes
结局指标
主要结局
Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume
时间窗: Retrospective up to 6 months after study completion
次要结局
未报告次要终点