Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Accuracy of Sensor by Arms Calculation
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 percentage 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 between the ages of 18 and 40 for each series of tests.
- •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 received the LNCS DBI Sensor.
干预措施: LNCS DBI Sensor (Device)
结局指标
主要结局
Accuracy of Sensor by Arms Calculation
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(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of these 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