Pulse Oximeter Response TO Multiple Levels Of Stable Hypoxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level
研究概览
简要总结
A clinical study designed to determine the accuracy of the peripheral capillary oxygen saturation (SpO2) function of the Vital Signs Patch (VSP) device for measuring blood saturation level.
详细描述
The clinical study protocol was designed for determining the accuracy of the SpO2 function of the Vital Signs Patch device for measuring blood oxygen saturation level, according to the guidelines for "evaluating and documenting SpO2 accuracy in human subjects" as set out in Annex EE of ISO 80601-2-61. Section 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 33 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 23 to
- •Skin tone varied from light to dark.
排除标准
- 未提供
结局指标
主要结局
Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level
时间窗: within 24 hrs
Successful capture of SpO2 levels - Infrared and red light absorbency was measured and used for SpO2 percentage calculation from both the Vital Signs Patch (VSP) study device and an invasive Blood Arterial Hemoximeter (standard method) to determine the level of accuracy of data obtained from the VSP device when compared data taken from the Arterial Hemoximeter. A comparison was made by calculating the Average Root Mean Square (Arms) and comparing against the Arms error rate limit of less than or equal to 3.5% at a 95% confidence level. The outcome is either positive or negative - this is a composite outcome measure.
次要结局
未报告次要终点