A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Accuracy of SpO2
研究概览
简要总结
It is important to evaluate the accuracy of the pulse oximeter, which is commonly used in clinical practice. The US FDA only allows the use of devices that meet the ISO 80601-2-61:2017 standard in the United States. According to the ISO 80601-2-61:2017 standard, the accuracy of the oxygen saturation (SpO2) of the pulse oximeter should have an error range of less than 4.0% compared to the actual arterial blood oxygen saturation (SaO2) in the range of 70-100%. To prove compliance with this requirement, it is necessary to conduct a clinical trial that induces hypoxemia in healthy adults and compares and evaluates the arterial blood oxygen saturation values of the pulse oximeter's SpO2 and the arterial blood oxygen saturation values of the carbon monoxide-oxygen meter (CO-oximeter).
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults between 20 and 50 years
- •volunteers who have plasma proportion of carboxyhemoglobin 3%
- •volunteers who have plasma proportion of methemoglobin 2%
- •volunteers who have total plasma hemoglobin concentration over 10 g/dL
排除标准
- •History of respiratory diseases
- •History of cardiovascular disease
- •Smokers (including ex-smokers)
- •History of fainting
- •History of diabetes
- •Obesity (BMI> 30 kg/m2)
- •Allen's test results, those who do not recover the color of their fingers and palms within 10 seconds
- •History of allergic reaction to lidocaine, a local anesthetic
结局指标
主要结局
Accuracy of SpO2
时间窗: 2 day
The root-mean-square of the difference between the observed pulse oximetry value (SpO2) and the carbon monoxide-oxygenometer arterial blood reference value (SRi) within the range of 70-100% of arterial oxygen saturation
次要结局
未报告次要终点