Clinical Validation of the Spirohome Clinic Ultrasonic Spirometer in Child and Adolescent Patients

Spirometers are critical devices that reveal the respiratory dynamics caused by respiratory problems and their severity and facilitate their diagnosis and follow-up. Hand-held spirometers have emerged relatively recently and offer several advantages over conventional desktop systems. There remains, however, a need for reassurance of high-quality spirometry testing with next-generation portable spirometers that connect over Bluetooth to smart device applications. In this study, we examine the accuracy and repeatability of lung function measurements of a novel hand-held ultrasonic spirometer, the Spirohome Clinic and compare its clinical performance to a reference device, the EasyOne Air. Benchtop validation of the spirometers was conducted using a lung simulator device according to ATS/ERS guidelines and the ISO 26782 standard waveforms. Subsequently, 48 volunteers (pediatric patients between 6 and 11 years of age and adolescent patients between 12 and 18 years of age) performed spirometry with both the Spirohome Clinic and the EasyOne Air spirometer during their clinic visits. Spirometric data including repeated FEV , FVC, FEV , FEF , and PEF measurements were collected. Both the Spirohome Clinic and the EasyOne Air successfully passed requirements for accuracy stated in relevant guidelines and standards for spirometry. The only statistically significant (