NCT01306201已完成不适用
A Novel Cardio-Respiratory Parameter in a Hospital Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.
研究概览
简要总结
Data collected from this study will be used to evaluate the performance of a monitoring algorithm.
详细描述
The goal of this study is to assess equivalency, performance, and accuracy of a new monitoring algorithm in a hospital setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 years old or older
- •Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures
- •Subjects on general care floor
排除标准
- •Severe contact allergies to standard adhesive materials
- •Abnormalities that may prevent proper application of the device
- •Women who are pregnant or lactating
- •Subjects with significant arrhythmia
结局指标
主要结局
The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.
时间窗: Participants were monitored for average of 30 minutes
Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.
次要结局
- The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.(Participants were monitored on average for 30 minutes)
研究者
研究点 (2)
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