NCT01791582已完成不适用
Respiration Rate Parameter Studies in Healthy Volunteers Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- ME (mean error) of Respiration Rate values for each subject
研究概览
简要总结
To assess performance of resp rate parameter in a monitoring system PCBA-1
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects ages 18 or older.
- •Subject is willing and able to provide written consent.
排除标准
- •Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
- •Subjects with abnormalities that may prevent proper application of the device.
- •Subjects with significant Arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse within thirty seconds).
- •Women who are pregnant or lactating.
结局指标
主要结局
ME (mean error) of Respiration Rate values for each subject
时间窗: 1-2 hours per subject
次要结局
未报告次要终点
研究者
研究点 (1)
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