Validation of portable Bluetooth enabled smart spirometer (Alveoair™) for the measurement of various lung functions in healthy subjects

Abstract

Background: Alveoair™ is a fully indigenously developed turbine operated handheld and portable Bluetooth enabled smart spirometer. Affordable Bluetooth enabled smart spirometers like Alveoair™ have been designed and developed to meet the challenges of patients with lung tissue disorders with aims to provide constant monitoring of the lung conditions and identify the degree of prognosis of the diseases before and after treatment. During the current pandemic of coronavirus disease 2019, lung function is severely affected. Spirometry is one of the most important tools in the investigation and monitoring of the patients with respiratory pathology and helps establish diagnosis for various lung diseases through the evaluation of lung functions and curves. Aims and Objectives: The objective of the present study is validation of Alveoair™ spirometer accuracy with Food and Drug Administration 510K Notified and CE approved spirometer NuvoAir in measuring lung capacity with various parameters limited to forced vital capacity (FVC), forced expiratory volume (FEV)1, peak expiratory flow (PEF), and FEV1/FVC measurement readings. Materials and Methods: The present study was done on 60 healthy subjects without any risk factors affecting pulmonary functions and all the necessary precaution taken during the period of study. Pulmonary function test was performed by both Alveoair™ and NuvoAir devices on each of the subjects for result comparisons. Results: It is evident that measurements parameters FVC, FEV1, PEF, and FEV1/FVC by the Alveoair™ have demonstrated parity with NuvoAir measurement with high Pearson and interclass correlation coefficient >90%, r2 value of FVC, FEV1, and PEF >90% and for FEV1/FVC ratio >80% and P-value for all the parameters