Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Similarity of SpO2 readings
研究概览
简要总结
The aim of the study is to compare the accuracy of peripheral blood oxygen saturation measurements using smartwatches from three manufacturers compared to a standard medical pulse oximeter.
详细描述
The aim is to create a study that compares multiple smartwatch models simultaneously with a standard medical pulse oximeter using a single measurement methodology. According to the available literature, no such study exists. The methodology of the study and the subsequent statistical evaluation are based on the guidelines of the standard ČSN EN ISO 80601-2-61, which specifies requirements for the basic safety and necessary functionality of pulse oximetry devices. The comparison will be performed non-invasively in healthy volunteers during gradual desaturation in the range of 70-100 % SpO2 (normobaric hypoxia). The data obtained could help to increase the awareness of the possibilities of SpO2 monitoring using smartwatches in medical conditions that are manifested by a decrease in SpO2 level over a longer time period, where measurement with a conventional oximeter is impractical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 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: wrist circumference, heart rate, blood pressure and blood oxygen saturation
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
First smartwatch model
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 experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously.
干预措施: Hypoxia and Smartwatch model (Other)
Second smartwatch model
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 experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously.
干预措施: Hypoxia and Smartwatch model (Other)
Third smartwatch model
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 experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously.
干预措施: Hypoxia and Smartwatch model (Other)
结局指标
主要结局
Similarity of SpO2 readings
时间窗: Under 1 hour
The agreement of SpO2 measurements of every model of smartwatches and reference pulse oximeter will be evaluated
次要结局
未报告次要终点