CareTaker Respiratory Rate Detection Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Respiration rate detection with accuracy of better than 3 breaths per minute
研究概览
简要总结
The goal of the proposed study is to test the capability of the CareTaker monitor to extract the respiration signature from its acquired signal, and to determine a respiration rate of breaths/minute that meets or exceeds the performance levels of its predicate device.
详细描述
The goal of the proposed study is to test the capability of the CareTaker monitor to extract the respiration signature from its acquired signal, and to determine a respiration rate of breaths/minute that meets or exceeds the performance levels of its predicate device.
The detection approach of RSPR (respiratory rate) that the CareTaker technology takes is based on peak detection and pulse analysis of arterial pressure pulse signals, as well as spectral analysis of the raw CareTaker sensor signal.
The study was performed under the supervision of the Chesapeake IRB and involved 21 subjects >18 y who were monitored during spontaneous and metronome-paced breathing.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 18 years of age, who are able and willing to participate and have given verbal assent
排除标准
- •Unable to give written consent
- •<18 years of age
- •No or poor finger pulse, as determined through visual inspection for ischemic hands
结局指标
主要结局
Respiration rate detection with accuracy of better than 3 breaths per minute
时间窗: 15 minutes of matched respiration rates
Comparison with performance of predicate device (accuracy within 3 breaths per minute).
次要结局
未报告次要终点