Validation of B.O.L.T Spirometer Device to test functioning of lungs with comparision to another Spirometer available in the market.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- 1. COPD2. Asthma3. Chronic bronchitis4. Emphysema5. Pulmonary fibrosis 6. Patient on a bronchodialator therapy
- Registration Number
- CTRI/2018/09/015691
- Lead Sponsor
- American Megatrends India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 91
Inclusion Criteria
1. Subject is willing to give written informed consent for participation in the study.
2. Male or Female, aged 18 years or above.
3. Subjects suffering from any respiratory disorder (COPD, Asthma, Chronic bronchitis, Emphysema and Pulmonary fibrosis)
4. Patient on a bronchodialator therapy
Exclusion Criteria
1. Mentally retarded subjects
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of the device with respect to the qualitative evaluation of the tracings with subsequent equivalent of <br/ ><br>1. Volume of air inhaled <br/ ><br>2. Volume of air exhaled <br/ ><br>3. Forced expiratory volume in one second(FEV1) <br/ ><br>4. Forced vital capacity (FVC) <br/ ><br>5. FEV1 divided by FVC (FEV1/FVC) <br/ ><br>6. PEF (Peak Expiratory Flow) <br/ ><br>7. FEF25-75% (Forced Expiratory Flow) <br/ ><br>8. FVC % Predicted <br/ ><br>9. FEV1 % Predicted <br/ ><br>10. FEV1 reversibility (ml) <br/ ><br>11. FEV1 reversibility % <br/ ><br>Timepoint: Same Day
- Secondary Outcome Measures
Name Time Method Turnaround time (TAT) will be calculated and compared for the following parameters for B.O.L.T. Spirometer with subsequent equivalent <br/ ><br>1. Device setup (installation) time <br/ ><br>2. Per-cycle loading and unloading time <br/ ><br>3. Overall time for the test <br/ ><br>Timepoint: same day