Clinical Validation of Internet of Things (IoT) based Smart Spirometer and Smart Mask for COPD patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- Age, sex and comorbidities are measured. The sensitivity, specificity, positive and negative predictive value and likelihood ratio between the three devices for detection of obstruction.
研究概览
简要总结
The project involves testing of Internet of Things based Smart Mask and Smart Spirometer developed and prototyped by IIT Kharagpur. Since the currently used Commercial Spirometer is cumbersome and standalone machine, the need for more flexible, robust, point of care devices are the need of the hour. In addition, the existing devices are not sensitive in detecting early forms of COPD. If more handy, remotely connected devices are validated it could be a game changer in the context of COVID-19 or in assessing patients remotely and suggesting modification of treatment by physician or advising admission, which could be life saving. Therefore in the era of precision medicine there is immense utility especially when India is facing an ongoing COPD epidemic.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years.
- •Modified Medical Research Council grade 0 to
- •Post bronchodilator Spirometry values less than or equal to 0.
- •Spirometry COPD GOLD Grade 1-3.
排除标准
- •Age less than 18 years Modified Medical Research Council grade 4 Spirometry GOLD Grade 4 Pregnant Women Extensive Bronchiectasis, Cystic Fibrosis) History of other Lung diseases (e.g. Pulmonary Tuberculosis, Pulmonary Fibrosis Previous Lung Surgery Active Cancer under Treatment, Suspected Lung Cancer Metal in the Chest Recent Eye Surgery Myocardial Infarction, Unstable Angina Recent Chest or Abdominal Surgery.
结局指标
主要结局
Age, sex and comorbidities are measured. The sensitivity, specificity, positive and negative predictive value and likelihood ratio between the three devices for detection of obstruction.
时间窗: Time points will be assessed at baseline.
次要结局
- To collect data on usability evaluation of these devices by the patients, operator & investigators.(Time points will be assessed at baseline.)
研究者
Krishnarajasekhar Ottilingam Radhakrishnan
Saveetha Institute of Medical and Technical Sciences, Saveetha University