MightySat - Clinical Performance Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Accuracy of RRp Determination
研究概览
简要总结
This study compares the performance of respiratory rate from pleth (RRp) measured with MightySat device on healthy subjects.Subjects will be asked to breathe at specific rates ranging from 5 to 30 breaths per minute.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 45 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
- •Younger than 18 years old, older than 45 years old
- •ASA physical status of III, IV, and 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 sensors will be applied (neck)
- •Excluded at Principal Investigator's discretion
研究组 & 干预措施
MightySat Test group
The subjects will be enrolled into the test group and will receive the MightySat investigational pulse oximeter.
干预措施: MightySat (Device)
结局指标
主要结局
Accuracy of RRp Determination
时间窗: approximately 30-40 minutes
Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the MightySat to the respiratory rate (RR) reference and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the MightySat 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 Error value.
次要结局
未报告次要终点