NCT01324817Unknown不适用
Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body.
详细描述
The purpose of this study is to test two remote, Doppler radar-based sensors to measure and monitor respiratory rate. Specifically, in clinically stable neonatal patients the study aims to:
- Obtain respiratory effort data of neonatal patients with remote Doppler radar systems modified from a system cleared by the FDA for adult use.
- Determine if remote Doppler radar systems can accurately detect the respiratory rate of neonatal patients, compared with standard measurement systems.
- Determine if unattended Doppler radar systems, operating for 4 hours, can accurately detect the respiratory rate of neonatal patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 2 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically stable
排除标准
- •Clinically unstable
- •Hypotensive requiring pressors
- •Intubated
- •Scheduled or planned (e.g., CT scan, central line placement) procedure during the study period.
研究者
研究点 (1)
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