PULSE OXIMETRY Performance Test for Vitacam. Controlled Desaturation Test.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Accuracy of oxygen saturation measurements - Root Mean Square Error
研究概览
简要总结
This clinical investigation aims to collect data for algorithm development and testing of Vitacam as well as to later validate the system using a simultaneously collected, but segregated, hold-out validation dataset. Vitacam is a software medical device for measuring vital signs, manufactured by NE Device SW Oy. It analyses digital video recorded using a smart device with a camera to locate a subject's face and chest region. From both these regions of interest, the video is further analysed to obtain the heart rate, heartbeat intervals, respiratory rate and oxygen saturation. These measurements are used as inputs to clinical decision making. Vitacam uses remote photoplethysmography to obtain the heart rate and heartbeat intervals, and will build on this to obtain oxygen saturation using information from red-green-blue channels.
The main focus of this study is to validate the oxygen saturation, heart rate and heartbeat intervals measured by Vitacam against gold standard references, applying the ISO 80601:2019 standard.
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
- •Age: 18-40 years
- •ASA category 1
- •Positive Allen's test
- •Passing the physical examination
- •Ability to give informed consent
- •Volunteering for the study
- •Fluent Finnish or English
排除标准
- •Age under 18 years or over 40 years
- •Pregnancy
- •Does not pass the physical examination
- •Negative Allen's test
- •Relevant medical illnesses
- •Cardiovascular disease
- •Pulmonary disease
- •Inability to give informed consent
结局指标
主要结局
Accuracy of oxygen saturation measurements - Root Mean Square Error
时间窗: A 30-45 minute period during which the participant is subjected to the de-saturation process
Accuracy as measured by Root Mean Square Error should be less than or equal to 4% for SpO2 as per ISO 80601-2-61:2019. It is calculated from the difference of the SpO2 measured from the investigational device and that of the reference device.
Accuracy of oxygen saturation measurements - Mean absolute error
时间窗: A 30-45 minute period during which the participant is subjected to the de-saturation process
Accuracy as measured by Mean Absolute Error should be less than or equal to 4% for SpO2 as per ISO 80601-2-61:2019. It is calculated from the difference of the SpO2 measured from the investigational device and that of the reference device.
次要结局
- Accuracy of interbeat intervals of the investigational device against successive R waves of the QRS complex from an Electrocardiogram(A 30-45 minute period during which the participant is subjected to the de-saturation process)