Top

Published in:

Open Access 01-12-2024 | Chronic Obstructive Lung Disease | Research

Comparison of a portable, pneumotach flow-sensor–based spirometer (Spirofy™) with the vitalograph alpha Touch™ spirometer in evaluating lung function in healthy individuals, asthmatics, and COPD patients—a randomized, crossover study

Authors: Deepak Talwar, S Balamurugan, Mahavir Modi, Sundeep Salvi, Meena Lopez, Rushika Shah, Abhijit Vaidya, Monica Barne, Sapna Madas, Nandan Kulkarni, Sandesh Sawant, Jaideep Gogtay

Published in: BMC Pulmonary Medicine | Issue 1/2024

Abstract

Background

Spirofy™ is India’s first portable, pneumotach flow-sensor-based digital spirometer developed to diagnose asthma and chronic obstructive pulmonary disease (COPD). In this study, we compared the performance of the Spirofy™ device with that of the Vitalograph Alpha Touch™ spirometer in measuring the lung capacities of healthy individuals, asthmatics, and COPD patients. We also assessed the inter-device variability between two Spirofy™ devices.

Methods

In a randomized, three-way crossover, open-label study, we measured the differences in forced expiratory volume in the first second (FEV₁) and forced vital capacity (FVC) between the Spirofy™ and Vitalograph Alpha Touch™ spirometers. A proportion of the FEV₁/FVC ratio distribution of < 0.7 was used to compare the diagnostic accuracies of the Spirofy™ with Vitalograph™ Alpha Touch™ spirometers.

Results

Ninety subjects participated in this study. The mean ± SD FVC values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 2.60 ± 1.05 L, 2.64 ± 1.04 L, and 2.67 ± 1.04 L, respectively. The mean ± SD FEV₁ values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 1.87 ± 0.92 (L), 1.88 ± 0.92 (L), and 1.93 ± 0.93 (L), respectively. A significant positive correlation was found between the FVC and FEV₁ values recorded by Vitalograph Alpha Touch™, Spirofy™ 1, and Spirofy™ 2. As compared to Vitalograph Alpha Touch™, the Spirofy™ device showed good sensitivity (97%), specificity (90%), and overall accuracy (93.3%) at an FEV₁/FVC ratio < 0.7. No inter-device variability was observed between the two Spirofy™ devices.

Conclusion

Spirofy™ is a portable and easy-to-use device and is as accurate as the standard Vitalograph Alpha Touch™ spirometer for the diagnosis of COPD and asthma.

Trial registration

CTRI/2021/09/036492 (Clinical Trials Registry - India)

Available only for authorised users

Cukic V, Lovre V, Dragisic D, et al. Asthma and chronic obstructive pulmonary disease (COPD) - differences and similarities. Mater Sociomed. 2012;24:100–5.CrossRefPubMedPubMedCentral

Soler X, Ramsdell JW. Are asthma and COPD a continuum of the same disease? J Allergy Clin Immunol Pract. 2015;3:489–95.CrossRefPubMed

Global Asthma Report. Available at: http://globalasthmareport.org/2018/resources/Global_Asthma_Report_2018.pdf. Accessed 1 Apr 2022.

GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the global burden of disease study 2019. Lancet. 2020;396:1204–22.

Poongadan MN, Gupta N, Kumar R. Lifestyle factors and asthma in India: a case-control study. Adv Respir Med. 2016;84:104–8.

Daniel RA, Aggarwal P, Kalaivani M, et al. Prevalence of chronic obstructive pulmonary disease in India: a systematic review and meta-analysis. Lung India. 2021;38:506–13.CrossRefPubMedPubMedCentral

Salvi S, Madas S, Ghorpade D, et al. Is underuse of inhaled corticosteroids for asthma in India contributing to 42% of global asthma deaths? Lung India. 2022;39:331–6.CrossRefPubMedPubMedCentral

Spirometry. Thinking beyond the COPD gold standard. Available at: https://www.patientcareonline.com/view/spirometry-thinking-beyond-copd-gold-standard. Accessed on: 09 December 2022.

Lamb K, Theodore D, Bhutta BS. Spirometry. [Updated 2022 Jul 18]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan–2022 Sep 6. Available at: https://www.ncbi.nlm.nih.gov/books/NBK560526/. Accessed on: 21 March 2023.

10.

Johns DP, Walters JA, Walters EH. Diagnosis and early detection of COPD using spirometry. J Thorac Dis. 2014;6:1557–69.PubMedPubMedCentral

11.

Wells CD, Joo MJ. COPD and asthma: diagnostic accuracy requires spirometry. J Fam Pract. 2019;68:76–81.PubMed

12.

Graham BL, Steenbruggen I, Miller MR, et al. Standardization of spirometry 2019 update. An official American thoracic society and European respiratory society technical statement. Am J Respir Crit Care Med. 2019;200:e70–88.CrossRefPubMedPubMedCentral

13.

Miller MR, Hankinson J, Brusasco V. ATS/ERS task force: standardization of lung function testing. Eur Respir J. 2005;26:319–38.CrossRefPubMed

14.

Barr RG, Stemple KJ, Mesia-Vela S, et al. Reproducibility and validity of a handheld spirometer. Respir Care. 2009;53(4):433–41.

15.

HernaÂndez CR, FernaÂndez MN, SanmartõÂn AP, et al. Validation of the portable air-smart spirometer. PLoS ONE. 2018;13:e0192789–99.CrossRef

16.

Kavanagh J, Jackson DJ, Kent BD. Over- and under-diagnosis in asthma. Breathe. 2019;15:e20–7.CrossRefPubMedPubMedCentral

17.

Singh S, Salvi S, Mangal DK, et al. Prevalence, time trends and treatment practices of asthma in India: The Global Asthma Network study. ERJ Open Res. 2022;8:00528–2021.CrossRefPubMedPubMedCentral

18.

Halpin DMG, Celli BR, Criner GJ, et al. The GOLD Summit on chronic obstructive pulmonary disease in low- and middle-income countries. Int J Tuberc Lung Dis. 2019;23(11):1131–41.CrossRefPubMed

19.

Agusti A, Fabbri LM, Baraldi E, et al. Spirometry: a practical lifespan predictor of global health and chronic respiratory and non-respiratory diseases. Eur J Intern Med. 2021;89:3–9.CrossRefPubMed

20.

Milanzi EB, Koppelman GH, Oldenwening M, et al. Considerations in the use of different spirometers in epidemiological studies. Environ Health. 2019;18:1–8.CrossRef

21.

Ring B, Burbank AJ, Mills K, et al. Validation of an app-based portable spirometer in adolescents with asthma. J Asthma. 2021;58:497–504.CrossRefPubMed

22.

Dickens AP, Fitzmaurice DA, Adab P, et al. Accuracy of Vitalograph lung monitor as a screening test for COPD in primary care. Care Respir Med. 2020;30:2–9.

23.

Boros PW, Maciejewski A, Nowicki MM, et al. Comparability of portable and desktop spirometry: a randomized, parallel assignment, open-label clinical trial. Adv Respir Med. 2022;90:60–7.CrossRef

24.

Zhou J, Li X, Wang X, et al. Accuracy of portable spirometers in the diagnosis of chronic obstructive pulmonary disease: a meta-analysis. Care Respir Med. 2022;32:15–27.

25.

Avdimiretz N, Wilson D, Grasemann H. Comparison of a handheld turbine spirometer to conventional spirometry in children with cystic fibrosis. Pediatr Pulmonol. 2020;55:1394–9.CrossRefPubMed

26.

Carpenter DM, Jurdi R, Roberts CA, et al. A review of portable electronic spirometers: implications for asthma self-management. Curr Allergy Asthma Rep. 2018;18:53–62.CrossRefPubMed

27.

Duong M, Rangarajan S, Zaman M, et al. Differences and agreement between two portable hand-held spirometers across diverse community-based populations in the prospective Urban Rural Epidemiology (PURE) study. PLoS Glob Public Health. 2022;2(2):e0000141.

Title: Comparison of a portable, pneumotach flow-sensor–based spirometer (Spirofy™) with the vitalograph alpha Touch™ spirometer in evaluating lung function in healthy individuals, asthmatics, and COPD patients—a randomized, crossover study
Authors: Deepak Talwar
S Balamurugan
Mahavir Modi
Sundeep Salvi
Meena Lopez
Rushika Shah
Abhijit Vaidya
Monica Barne
Sapna Madas
Nandan Kulkarni
Sandesh Sawant
Jaideep Gogtay
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: Chronic Obstructive Lung Disease
Bronchial Asthma
Spirometry
Published in: BMC Pulmonary Medicine / Issue 1/2024
Electronic ISSN: 1471-2466
DOI: https://doi.org/10.1186/s12890-024-02972-4

Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Reserve your place

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin

Prof. Florian Limbourg

Prof. Anoop Chauhan

Developed by: Springer Medicine

Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2024

Clinical trends among patients with asthma hospitalized for COVID-19 based on data from a nationwide database: an observational study

Penehyclidine hydrochloride alleviates lung ischemia-reperfusion injury by inhibiting pyroptosis

Contribution of small airway inflammation to the development of COPD

Diagnosis model of early Pneumocystis jirovecii pneumonia based on convolutional neural network: a comparison with traditional PCR diagnostic method

Bronchoscopic lung volume reduction by instillation of fibrinogen and thrombin in COPD patients with homogenous emphysema

Predictive value of radiomic features extracted from primary lung adenocarcinoma in forecasting thoracic lymph node metastasis: a systematic review and meta-analysis

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

At a glance: The STEP trials