SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Is there any difference in measured SpO2 between finger and wrist during induced hypoxia?
研究概览
简要总结
The aim of the project is to experimentally compare SpO2 measured on a wrist by commercial Smartwach and on a finger measured by a medical-grade pulse oximeter in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).
详细描述
The newest models of smartwatches measure peripheral blood oxygen saturation (SpO2) and the technology is rapidly improving. The results of individual studies on the accuracy of SpO2 measurement using smartwatches from different brands are still inconclusive. The study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. The agreement of the measurements of both devices will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure, blood oxygen saturation and medical history
排除标准
- •pregnancy
- •severe cardiovascular conditions
- •severe asthma or other severe respiratory conditions
- •injury to the upper limbs or hands that could affect the peripheral perfusion
- •hypotension or hypertension
研究组 & 干预措施
Hypoxia
Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the whole experiment, non-invasive SpO2 measurements will be performed on the middle finger and on the wrist of left hand.
干预措施: Breathing mixtures of O2 and N2 and monitoring SpO2 on finger and left wrist (Other)
结局指标
主要结局
Is there any difference in measured SpO2 between finger and wrist during induced hypoxia?
时间窗: 1 hour
The agreement of SpO2 measurements of both monitoring devices will be evaluated.
次要结局
未报告次要终点