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Validation of B.O.L.T Spirometer Device to test functioning of lungs with comparision to another Spirometer available in the market.

Validation of B.O.L.T VA08 Spirometer Device to test lung function with reference to subsequent equivalent.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/09/015691
Enrollment
100
Registered
2018-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- 1. COPD 2. Asthma 3. Chronic bronchitis 4. Emphysema 5. Pulmonary fibrosis 6. Patient on a bronchodialator therapy

Interventions

Control Intervention1: Philips M8002A: It is a Medical Device, available in the market and is used to do Spirometry

Sponsors

American Megatrends India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Mentally retarded subjects

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of the device with respect to the qualitative evaluation of the tracings with subsequent equivalent of 1. Volume of air inhaled 2. Volume of air exhaled 3. Forced expiratory volume in one second(FEV1) 4. Forced vital capacity (FVC) 5. FEV1 divided by FVC (FEV1/FVC) 6. PEF (Peak Expiratory Flow) 7. FEF25-75% (Forced Expiratory Flow) 8. FVC % Predicted 9. FEV1 % Predicted 10. FEV1 reversibility (ml) 11. FEV1 reversibility % Timepoint: Same Day—

Secondary

MeasureTime frame
Turnaround time (TAT) will be calculated and compared for the following parameters for B.O.L.T. Spirometer with subsequent equivalent 1. Device setup (installation) time 2. Per-cycle loading and unloading time 3. Overall time for the test Timepoint: same day—

Countries

India

Contacts

Public ContactSubham Dutta

American Megatrends India Private Limited

divyak@amiindia.co.in9790917069

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026