A Test of the Spot Respiration Rate Accuracy of the New Reassure Device on Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 20
- 主要终点
- Respiration Rate Accuracy
研究概览
简要总结
A trial conducted within the company with a new non-contact respiration rate (RR) sensor. The device was compared for accuracy in RR measurement with a cleared device, the SOMNOScreen Easy, which uses chest effort bands.
The RR was measured over a short duration on subjects sitting upright in a chair, with the non-contact sensor at various distances from the subject. A total of 20 subjects were tested, from both genders, selected to represent a wide range of age and body mass index
详细描述
The Reassure uses Radio Frequency (RF) waves to detect the small movements of the human body due to respiration. The reference device, the SOMNOScreen, uses chest effort bands. The Reassure is non-contact and so more comfortable and convenient for quick RR measurement, in a similar way that an Infra-Red thermometer is compared to a traditional under-the-tongue mercury thermometer.
The aim is to explore the variations in the human body that could have an effect on the radio reflection from the human torso, and thus affect the potential detection and accuracy of breathing rate. Factors that could affect non-contact RF performance are:
- High Body Mass Index (BMI) could potentially reduce the chest wall movement during breathing, or alter the nature of the breathing.
- Elderly, thin skin (ie pensioner with low BMI) may have less RF reflection.
- Female breast tissue may have an effect on detection or accuracy.
This was tested at a number of distances from the non-contact sensor and also with the subject having a thick comforter (duvet) laid across them.
The test conditions were
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Greater or equal to 18 years old and less than or equal to 75 years old
- •BMI within the range of greater or equal to 18 and less than or equal to 45
排除标准
- 未提供
结局指标
主要结局
Respiration Rate Accuracy
时间窗: Recording duration of 2 minutes; measurement made after 45 seconds settling time, for at least 60 seconds
The respiration rate measured contemporaneously by the Reassure and the reference device, SomnoScreen, are compared on a second-by-second basis, over the recording duration. The difference between the two respiration rate measurements (the delta) for all 20 subjects' recordings, in all positions, are plotted on a normal distribution chart, giving 8,800 data points. The distribution chart reveals the mean difference between the two devices' measurements and the Standard Deviation (SD). The measure of success is if the 95% (ie 2SD) of the difference in the respiration rate indicated by the two devices (the delta) is less than 5 breaths per minute. This measure is derived from the peer review paper by Lim et al, cited in the References section
次要结局
未报告次要终点