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

Abstract

Background

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.

Methods

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 FEV₁, FVC, FEV₆, FEF_25-75, and PEF measurements were collected.

Results

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 (p<0.05) difference was for FVC measurement accuracy. Clinical comparisons revealed strong correlation between spirometers in the measurement of key pulmonary function parameters including FEV₁ and FVC with a Pearson's correlation coefficient of 0.99. Bland–Altman plots showed good agreement between mean differences of FEV₁ and FVC with the majority measurements remaining between the limits of 95% agreement for both the entire patient cohort and also in age and gender subsets.

Conclusion

The present study demonstrated that the Spirohome Clinic spirometer conforms to ATS/ERS performance requirements and validates the clinical comparability of its measurement accuracy and repeatability to the EasyOne Air. These findings support the indicated use of the Spirohome Clinic for high-quality lung function testing in clinical settings.

Keywords:

• handheld spirometer
• ultrasonic spirometer
• portable spirometer
• spirometry
• pediatric
• respiratory disease
• FEV1
• FVC

Abbreviations

ATS, American Thoracic Society; ERS, European Respiratory Society; COVID-19, Coronavirus disease – 19; FVC, forced vital capacity; FEV1, forced expiratory volume in 1 s; FEV6, forced expiratory volume in 6 s; PEF, peak expiratory flow; FEF25-75, forced expiratory flow at 25–75% (FEF_25-75) of forced vital capacity; BEV, back extrapolated volume; FET, Forced expiratory time.

Acknowledgments

The authors would like to thank Inofab Health for contributing the equipment used in this study including the spirometers and lung simulator device. The authors would also like to thank Deniz Ozdil and Dr Oya Kalaycioglu for their efforts in editing this paper and providing the statistical analyses of the data, respectively.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors have no conflicts of interest to declare.

Additional information

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Inofab Health Technologies have kindly provided the devices and test equipment used in this study and financial support for publication costs.