INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- RRp Arms of Sensor Accuracy
研究概览
简要总结
This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physical status of ASA I or II
- •Must be able to read and communicate in English
- •Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement.
- •Passed health assessment screening
- •Negative pregnancy test for female subjects of child bearing potential.
排除标准
- •Physical status of ASA III, IV, or V
- •Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
- •Inability to tolerate sitting still or minimal movement for at least 30 minutes
- •Positive pregnancy test for female subjects
- •Refusal to take pregnancy test for women of child bearing potential
- •Nursing female subjects
- •Subjects wearing acrylic nails or subjects refusing to remove nail polish
- •Subjects who have a nail deformity on the measurement finger
- •Subjects who do not have adequate skin integrity on the measurement finger
- •Excluded at the Principal Investigator's discretion
结局指标
主要结局
RRp Arms of Sensor Accuracy
时间窗: 1-5 hours
Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00032 and/or INVSENSOR00033 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.
次要结局
未报告次要终点