Perminova Respiratory Effort Accuracy Validation 09-12-2013-Rev 2
研究概览
地位
详细说明
After IRB Approval, eighteen volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate technology of the Perminova N4 Monitoring system (Device Under Test). The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMI's.
A range of stable respiratory rates will be elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35 and 40 breaths per minute; with some natural variation from these exact numbers.
Each subject will be instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be used as the Accuracy Reference Device (Reference) in this study. Performance of the currently released ECG Impedance Respiratory Rate monitor (Acceptance Standard) will be used to establish the acceptance criteria in this study by comparing to Reference.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Colorado
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Louisville、Colorado、美国、80027
- Clinimark Laboratory
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- male
- female
- 18-45
- range of physiques
- healthy
Exclusion Criteria:
- injury to sensor area
- skin inflammation
- implanted devices such as pacemakers
- pregnant
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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male female 18-45 years range of body types
18 male female subject mix that are 18-45 years of age and selected to represent a range of body types of varying physiques and body mass indexes
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Respiratory Rate of test subject as compared to end tidal CO2
大体时间:1 week
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1 week
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 78o944o
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