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

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. The...

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Autores principales: Sekerel, Bulent Enis, Unsal, Hilal, Sahiner, Umit Murat, Uysal Soyer, Ozge, Damadoglu, Ebru, Karakaya, Gul, Kalyoncu, Ali Fuat
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2022
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Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8859473/
https://www.ncbi.nlm.nih.gov/pubmed/35210788
http://dx.doi.org/10.2147/JAA.S345189
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author Sekerel, Bulent Enis
Unsal, Hilal
Sahiner, Umit Murat
Uysal Soyer, Ozge
Damadoglu, Ebru
Karakaya, Gul
Kalyoncu, Ali Fuat
author_facet Sekerel, Bulent Enis
Unsal, Hilal
Sahiner, Umit Murat
Uysal Soyer, Ozge
Damadoglu, Ebru
Karakaya, Gul
Kalyoncu, Ali Fuat
author_sort Sekerel, Bulent Enis
collection PubMed
description 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 FEV(1), FVC, FEV(6), 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 FEV(1) and FVC with a Pearson's correlation coefficient of 0.99. Bland–Altman plots showed good agreement between mean differences of FEV(1) 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.
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spelling pubmed-88594732022-02-23 Clinical Validation of the Spirohome Clinic Ultrasonic Spirometer in Child and Adolescent Patients Sekerel, Bulent Enis Unsal, Hilal Sahiner, Umit Murat Uysal Soyer, Ozge Damadoglu, Ebru Karakaya, Gul Kalyoncu, Ali Fuat J Asthma Allergy Original Research 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 FEV(1), FVC, FEV(6), 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 FEV(1) and FVC with a Pearson's correlation coefficient of 0.99. Bland–Altman plots showed good agreement between mean differences of FEV(1) 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. Dove 2022-02-15 /pmc/articles/PMC8859473/ /pubmed/35210788 http://dx.doi.org/10.2147/JAA.S345189 Text en © 2022 Sekerel et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Original Research
Sekerel, Bulent Enis
Unsal, Hilal
Sahiner, Umit Murat
Uysal Soyer, Ozge
Damadoglu, Ebru
Karakaya, Gul
Kalyoncu, Ali Fuat
Clinical Validation of the Spirohome Clinic Ultrasonic Spirometer in Child and Adolescent Patients
title Clinical Validation of the Spirohome Clinic Ultrasonic Spirometer in Child and Adolescent Patients
title_full Clinical Validation of the Spirohome Clinic Ultrasonic Spirometer in Child and Adolescent Patients
title_fullStr Clinical Validation of the Spirohome Clinic Ultrasonic Spirometer in Child and Adolescent Patients
title_full_unstemmed Clinical Validation of the Spirohome Clinic Ultrasonic Spirometer in Child and Adolescent Patients
title_short Clinical Validation of the Spirohome Clinic Ultrasonic Spirometer in Child and Adolescent Patients
title_sort clinical validation of the spirohome clinic ultrasonic spirometer in child and adolescent patients
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8859473/
https://www.ncbi.nlm.nih.gov/pubmed/35210788
http://dx.doi.org/10.2147/JAA.S345189
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