Continous wearable device based Monitoring of Healthcare Professionals supporting Covid-19 patients for early screening of Covid-19 related symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fortis will distribute the wearable device Watch called ( Empatica E4 ) provided by TCS to consenting volunteers. The volunteer will wear the watch continously for 2 weeks , wherein the following metadata will be recorded. Heart rate, Spo2, Body temperature, height, weight, Blood pressure( recorded manually ), will be recorded against the USER ID provided to TCS.
研究概览
简要总结
This observational study called, Continous Wearable device based Monitoring of healthcare professionals supporting Covid -19 patients for early screening of Covid -19 related symptoms. This study is a prototype to test and predict with the Metadata collected by a wearable device ( Empatica E 4 ) by consenting doctors and nurses, who are directly involved in the treatment of covid 19 patients in ICU or Wards.
The study is basically to detect early warning for these healthcare workers , by means of information collected by the watches . The watches will record continously the PPG ( photoplythsmography ), GSR, Skin temperature, Heart rate, Respiratory rate and Accelerometer data.
As we know the Covid -19 patients are Happily Hypoxic with saturations ranging from 85% to 95% in room air, but still are asymptomatic. The idea is to capture the various parameter ( Meta data )and the Spo2 of our healthcare workers every 24 hours ( by downloading from the watch all data ), and analyzing in a software to look at the trend to see for temperature raise ,heart rate raise or Spo2 drop , in these individuals who are in Covid ward or ICU , looking after the patients,.
By looking at the Metadata , we are looking at fore Warning the doctors or nurses, regarding their deteriorating health ,while serving in these Covid wards . These people can be now be further evaluated , with a high suspicion to the viral disease and quarentined thereafter.
These wearable devices can also be used on people ,who are on home or Institutuional Quarentine for 14 or more days.
The study will be conducted in over 30 individuals , over a period of 1 month , in one hospital, which is treating Covid patients .
The Ethics approval has been obtained from Fortis hospital, kolkata vide reg no,. ECR/240/INST/WB/2013/RR-19 DATED 19TH MAY 2020
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All healthcare workers , assigned to Covid ward / ICU duties, includes Doctors and Nurses.
排除标准
- •Persons not involved in Covid -19 care wards/ICU.
结局指标
主要结局
Fortis will distribute the wearable device Watch called ( Empatica E4 ) provided by TCS to consenting volunteers. The volunteer will wear the watch continously for 2 weeks , wherein the following metadata will be recorded. Heart rate, Spo2, Body temperature, height, weight, Blood pressure( recorded manually ), will be recorded against the USER ID provided to TCS.
时间窗: Data to be analysed at Baseline, at 2 weeks, at 4 weeks and at 6 weeks
次要结局
- Can be used extensively as a wearable device ,for healthcare workers in Covid exposed settings and also persons in Quarentine , ...who can be detected or diagnosed early for treatment if Metadata / algorithm suggests, that the person has been exposed to the Covid-19 virus.(Baseline, at 2 weeks, at 4 weeks and at 6 weeks)