A Validation Study Comparing the Heart Rate, Respiratory Rate, Heart Rate Variability and Blood Pressure Obtained by Video Selfie Using DocMe® Technology With Those Obtained by Direct Measurement in Adults
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Respiratory Rate
研究概览
简要总结
The aim of this study is to compare accuracy of DocMe, a video technology developed by DocMe Health Technologies, with previously validated medical devices used for measurements of heart rate, heart rate variability, respiratory rate and blood pressure in adults.
详细描述
Photoplethysmography (PPG) makes uses of low-intensity infrared (IR) light. When light travels through biological tissues, it is absorbed by bones, skin pigments and both venous and arterial blood. However, as light is more strongly absorbed by blood than the surrounding tissues, the changes in blood flow can be detected by PPG sensors as changes in the intensity of light.
The signal from PPG is proportional to the quantity of blood flowing through the blood vessels and even small changes in blood volume can be detected using this method. Analysis of the waveform can provide information on a range of physiological measurements affecting the cardiovascular and respiratory systems. PPG is widely used in medicine in the form of pulse oximeters using sensors applied to peripheral digits.
Recently, it has been shown that PPG data can be obtained using images acquired from videos taken using the camera on smartphones and there is now a significant and growing body of published literature to support this.
DocMe Health Technologies has developed a system of obtaining these data using a video selfie.
At this time, the technology has been shown to be reasonably accurate when compared to home devices in healthy subjects. However, to make the technology more widely useful, the results obtained by video selfies need to be formally validated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (18 - 100 years old). Participants must be willing and able to give informed consent for participation in the study, and considered fit for the study by the nurse.
排除标准
- 未提供
结局指标
主要结局
Respiratory Rate
时间窗: Baseline
Respiratory Rate in breaths/min assessed visually or oximeter if it has the capability assessed 3 times at 10 minute intervals on one occasion
Heart Rate
时间窗: Baseline
Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion
Blood Pressure
时间窗: Baseline
Systolic and Diastolic Blood Pressure assessed 3 times at 10 minute intervals on one occasion
Heart Rate Variability
时间窗: Baseline
Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion
次要结局
未报告次要终点
