NCT03128827已完成不适用
Use of Rainbow Acoustic Monitoring in Pediatric Patients - A Clinical Engineering Data Collection Protocol
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Accuracy of RAM sensor to detect respiration rate
研究概览
简要总结
The study will capture high resolution waveform data and numerical data from three respiratory rate methods: end tidal CO2, impedance pneumography, and bioacoustic sensing (Rainbow Acoustic Monitoring, RAM).
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0 to 18 years old inclusive, male and female patients
- •Only patients with written informed consent signed by parents or legal guardians will be enrolled
- •In children 10 and older, patient's assent will be obtained
排除标准
- •Patients who are unable to give their consent and/or assent
- •Patients with skin abnormalities (rash, eczema, etc) at the planned application sites that would interfere with sensor, cannula or electrode applications
研究组 & 干预措施
Test Subjects
Experimental
All test subjects were pediatric patients following general anesthesia who received the RAM sensor which measures respiration rate.
干预措施: RAM sensor (Device)
结局指标
主要结局
Accuracy of RAM sensor to detect respiration rate
时间窗: 1-6 hours
Accuracy will be determined by comparing the noninvasive respiratory rate measurement of the sensor to that obtained from a reference and calculating the arithmetic root mean square (Arms) error value.
次要结局
未报告次要终点
研究者
研究点 (2)
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