Clinical validation of HealthCubed’s AgeWell device- a patient monitoring system for measuring vital parameters
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of performance of AgeWell Device in comparison to Philips SureSigns
研究概览
简要总结
COVID-19 has had a significant impact on the health of people across the world. With
restrictions in mobility, people have had to postpone or forego visits to the doctor. For those
with chronic conditions, this has meant extended periods of time without vital parameters
being tested and tracked. These have long term consequences on morbidity and mortality.
To address these issues, patients and healthcare providers are moving towards home based
patient monitoring systems that combine point-of-care testing with digital health services.
Patients can use such devices from the comfort of their homes and continue to receive care.
HealthCubed India Pvt Ltd has designed a multiparametric point-of-care device for home use
called AgeWell that measures blood pressure, oxygen saturation, temperature, respiratory
rate, heart rate and performs a single channel ECG. The current study is aimed at evaluating
its clinical performance.
This trial will compare the performance of AgeWell with FDA approved Philips SureSign
VM8 device for the following vital parameters - Blood Pressure, Oxygen saturation, Pulse
rate, Respiratory rate, Heart rate and Temperature.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.99 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of any sex, 18 years and older, can be enrolled in this study.
- •Subjects must consent to participating in the study.
排除标准
- •â— Pregnant women â— Smokers â— Individuals subject to conditions that result in elevated levels of methaemoglobin â— Subjects exhibiting injuries, intravenous lines, or other abnormalities that, in the opinion of the investigator, may prevent proper cuff application or functioning.
- •â— Subjects with compromised circulation or peripheral vascular disease â— Subjects with clotting disorders or taking blood thinners.
结局指标
主要结局
Assessment of performance of AgeWell Device in comparison to Philips SureSigns
时间窗: 2 weeks
次要结局
- Feedback from usability perspective by study performed over 50 subjects(2 weeks)