Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Accuracy of Sensor
研究概览
简要总结
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Competent non-smoking adults
- •Inclusion Criteria:
- •Subjects must understand and consent to be in the study.
- •American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).
排除标准
- •Subjects who have any systemic disease at all.
- •Subjects who do not understand the study and the risks.
- •Subjects who are pregnant.
- •Subjects having either signs or history of peripheral ischemia.
- •Others deemed ineligible by the clinical staff.
研究组 & 干预措施
Test Subject
All subjects are enrolled into the test group and all subjects receive the MightySat RX Pulse Oximeter Sensor.
干预措施: MightySat RX Pulse Oximeter Sensor (Device)
结局指标
主要结局
Accuracy of Sensor
时间窗: 1-5 hours
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value.
Accuracy of Sensor during motion
时间窗: 1-5 hours
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample during motion conditions and calculating the arithmetic root mean square error (Arms) value.
次要结局
未报告次要终点