Clinical Validation of Novel Smartphone-Based Spirometer for Measurement of Obstructive Diseases

2021 
Introduction: Spirometry, despite being the gold-standard diagnostic test for obstructive airway diseases, is underutilized in clinical practice. It is widely used to assess lung function and provide objective data for lung disease diagnosis and monitoring. Real-life conditions are less ideal because of comorbidities, age of the subjects, and a variety of airflow limitations. BRIOTA Technologies Private Limited has developed a portable and point-of-care diagnostic tool for Asthma and obstructive diseases. Objective: This descriptive and cross-sectional prospective study was carried out in the respiratory ward of a Semi-Government hospital located in Pune, Maharashtra, India. In this study, 126 patients with Chronic Obstructive Pulmonary Disease (COPD) and asthma were enrolled, with only a handful of them being healthy. SpiroPROTM is a turbine-based electronic measuring device integrated with an intuitive mobile application to perform spirometry analysis and generate a spirometry report. Furthermore, the apparatus allows us to incorporate a vital parameter representing Forced Expiratory Volume (FVC), Forced Expiratory Volume in the first second (FEV1) into the final diagnosis. Methods: We compared volumetric parameters as well as inhalation parameters using an Easy-ware air Spirometer device, a conventional spirometer to a house-developed SpiroPROTM device, and analyze the ability of this new portable device to detect obstructions and restrictions. Results: The concordance and relation of the FEV1 and FVC parameters were optimal. We used the absolute values as well as the percentages to make this comparison. The greatest difference in the measurement was in the FVC, which was 77.95 ml (95% CI: 38 to 117). Conclusion: This SpiroPROTM Spirometer device is a simple, easy-to-use, and highly accurate technology that may be used to screen and diagnose chronic respiratory disorders.
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