NCT05462886已完成不适用
Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Heart Rate Accuracy of Masimo INVSENSOR00057
研究概览
简要总结
This study is designed to compare the accuracy of a noninvasive measurement of heart rate compared to reference values obtained by a standard of care ECG monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 18 to 80 years of age.
- •Subject is able to read and communicate in English.
排除标准
- •Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
- •Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
结局指标
主要结局
Heart Rate Accuracy of Masimo INVSENSOR00057
时间窗: 1-3 hours
Heart rate accuracy was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values from Masimo INVSENSOR00057 (TestHR\_i) to the reference ECG monitor values (RefHR\_i). Arms= √(∑(i=1 to n) ((TestHR\_i-RefHR\_i )\^2 ))/n
次要结局
未报告次要终点
研究者
研究点 (2)
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