INVSENSOR00013 Respiratory Rate Clinical Performance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- RRp Arms of Sensor Accuracy
研究概览
简要总结
The objective of this prospective study is to compare the noninvasive respiration from pleth (RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured by capnography (RRref), Masimo's RAM technology and the manual annotation.
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
- •18 to 70 years old
- •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 judgement of the investigator, renders them inappropriate for participation in the 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
- •Refusal of male subjects to agree to shave hair off areas where the sensor will be applied (neck) when deemed necessary
- •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
研究组 & 干预措施
INVSENSOR00013 Test group
All subjects will be enrolled into the test group and will receive the INVSENSOR00013 investigational device.
干预措施: INVSENSOR00013 (Device)
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 INVSENSOR00013 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 INVSENSOR00013 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