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Comparison of a portable, pneumotach flow-sensor–based spirometer (Spirofy™) with the vitalograph alpha Touch™ spirometer in evaluating lung function in healthy individuals, asthmatics, and COPD patients—a randomized, crossover study
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Comparison of a portable, pneumotach flow-sensor–based spirometer (Spirofy™) with the vitalograph alpha Touch™ spirometer in evaluating lung function in healthy individuals, asthmatics, and COPD patients—a randomized, crossover study
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Comparison of a portable, pneumotach flow-sensor–based spirometer (Spirofy™) with the vitalograph alpha Touch™ spirometer in evaluating lung function in healthy individuals, asthmatics, and COPD patients—a randomized, crossover study
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Journal Article
Comparison of a portable, pneumotach flow-sensor–based spirometer (Spirofy™) with the vitalograph alpha Touch™ spirometer in evaluating lung function in healthy individuals, asthmatics, and COPD patients—a randomized, crossover study
2024
Overview
Background
Spirofy™ is India’s first portable, pneumotach flow-sensor-based digital spirometer developed to diagnose asthma and chronic obstructive pulmonary disease (COPD). In this study, we compared the performance of the Spirofy™ device with that of the Vitalograph Alpha Touch™ spirometer in measuring the lung capacities of healthy individuals, asthmatics, and COPD patients. We also assessed the inter-device variability between two Spirofy™ devices.
Methods
In a randomized, three-way crossover, open-label study, we measured the differences in forced expiratory volume in the first second (FEV
1
) and forced vital capacity (FVC) between the Spirofy™ and Vitalograph Alpha Touch™ spirometers. A proportion of the FEV
1
/FVC ratio distribution of < 0.7 was used to compare the diagnostic accuracies of the Spirofy™ with Vitalograph™ Alpha Touch™ spirometers.
Results
Ninety subjects participated in this study. The mean ± SD FVC values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 2.60 ± 1.05 L, 2.64 ± 1.04 L, and 2.67 ± 1.04 L, respectively. The mean ± SD FEV
1
values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 1.87 ± 0.92 (L), 1.88 ± 0.92 (L), and 1.93 ± 0.93 (L), respectively. A significant positive correlation was found between the FVC and FEV
1
values recorded by Vitalograph Alpha Touch™, Spirofy™ 1, and Spirofy™ 2. As compared to Vitalograph Alpha Touch™, the Spirofy™ device showed good sensitivity (97%), specificity (90%), and overall accuracy (93.3%) at an FEV
1
/FVC ratio < 0.7. No inter-device variability was observed between the two Spirofy™ devices.
Conclusion
Spirofy™ is a portable and easy-to-use device and is as accurate as the standard Vitalograph Alpha Touch™ spirometer for the diagnosis of COPD and asthma.
Trial registration
CTRI/2021/09/036492 (Clinical Trials Registry - India)
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
Subject
/ Aged
/ Asthma
/ Chronic obstructive pulmonary disease
/ Female
/ Humans
/ India
/ Male
/ Medicine
/ Pneumology/Respiratory System
/ Pulmonary Disease, Chronic Obstructive - diagnosis
/ Pulmonary Disease, Chronic Obstructive - physiopathology
/ Sensors
/ Severe acute respiratory syndrome coronavirus 2
