ung function test devices used are bulky and difficult to interpret in Chronic Obstructive Lung Disease. Smart Spirometer and Smart Mask are wireless devices which aim to overcome this. This study compares these results with existing Lung Function device.
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2024/01/061796
- Lead Sponsor
- Ministry of Electronics and Information Technology (MeitY), Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Age more than 18 years.
Modified Medical Research Council grade 0 to 3.
Post bronchodilator Spirometry values less than or equal to 0.7.
Spirometry COPD GOLD Grade 1-3.
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: Time points will be assessed at baseline.
- Secondary Outcome Measures
Name Time Method To collect data on usability evaluation of these devices by the patients, operator & investigators.Timepoint: Time points will be assessed at baseline.