Pulmonary Function Electronic Monitoring Devices: A Randomized Agreement Study

doi:10.1378/chest.128.3.1258

Chest

Volume 128, Issue 3, September 2005, Pages 1258-1265

https://doi.org/10.1378/chest.128.3.1258 Get rights and content

Study objectives

To compare in a clinical setting the within-session reproducibility of two pulmonary function electronic monitoring devices (PiKo-1; Ferraris Respiratory Europe; Hereford, UK; and Spirotel; MIR; Rome, Italy) with one mechanical device (Mini-Wright Peak-Flow Meter; Clement-Clarke International; Harlow, Essex, UK), and to evaluate the accuracy of these devices using as reference an office pneumotachograph.

Design, setting, and participants

After detailed instructions, adults without airways diseases and patients with stable asthma attending an outpatient clinic performed four sets of expiratory maneuvers, one set for each device, in a strictly random order. Each set comprised three maneuvers with 2 to 3 min of rest between them.

Measurements

Reproducibility of FEV₁ and peak expiratory flow (PEF) was assessed by a coefficient of variation (CV) and intraclass correlation coefficient (ICC), and accuracy was assessed by ICC and limits of agreement.

Results

Of the 38 participants evaluated, 71% were women and 61% had asthma. Ages ranged from 18 to 58 years, and FEV₁ ranged from 1.2 to 4.8 L. In all monitoring devices, CV was < 6% and ICC was > 0.94 for the reproducibility of both FEV₁ and PEF measurements. The accuracy of the PiKo-1 device was better for FEV₁ (ICC = 0.98) than for PEF (ICC = 0.90). The Spirotel device had similar results for FEV₁ and PEF (ICC = 0.95). The Mini-Wright device had the lowest accuracy (ICC = 0.87), particularly for PEF values < 500 L/min.

Conclusions

These low-cost and easy-to-use electronic monitoring devices showed a very good reproducibility and were in agreement with the pneumotachograph. Therefore, the PiKo-1 and Spirotel devices seem adequate for both screening and monitoring. However, prospective studies are still needed to assess their long-term reproducibility and usability and, particularly, the effects on the improvement of respiratory care.

Section snippets

Instruments

The PiKo-1 is a monitoring device that uses a patented pressure/flow sensor technology for PEF and FEV₁ measurement. Is a low-cost, pocket-size, easy-to-use device that can storage 96 measurements with date and time stamp, plus test-quality alerts indicating an abnormal blow or cough. It can measure PEF in the range of 15 to 999 L/min with a 1 L/min resolution and an accuracy of 6.5% or 15 L/min, whichever is greater. The measurement of FEV₁ has a range of 0.15 to 9.99 L (0.01-L resolution) and

Results

Thirty-eight patients were included. Their demographic characteristics, height, weight, smoking status, FEV₁, and PEF descriptive data are presented in Table 1. All individuals were white; 23 patients (61%) had asthma. Twenty-five patients (66%) had previous experience of using PEF meters, and 16 patients (42%) remembered performing spirometry previously.

Mean Asthma Control Questionnaire scores were 0.58 (SD, 0.51; minimum, 0; maximum, 1.83) for asthmatics and 0 (SD, 0; minimum and maximum, 0)

Main Findings

We have shown a very good reproducibility and an excellent agreement with an office pneumotachograph and both pulmonary function electronic monitoring devices. Additionally, we confirmed the low accuracy and the nonlinear response of the Mini-Wright PFM. The best agreement with the pneumotachograph was observed for PiKo-1 FEV₁, and the worst was observed for Mini-Wright PEF.

The inadequate performance of the Mini-Wright PFM is consistent with the observations of other studies.¹⁷, ¹⁸, ¹⁹, ²² In

Conclusion

The low-cost and easy-to-use electronic monitoring devices tested showed a very good reproducibility and were in agreement with the pneumotachograph. Therefore, they seem adequate both for screening and monitoring. However, prospective studies are needed to assess long-term reproducibility, usability, and especially the effects on the improvement of respiratory care.

ACKNOWLEDGMENT: We thank participants for their cooperation, Ms. Sandra Gomes for assisting with data collection, Dr. Cristina

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Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).

Participating institutions (Hospital São, Joao and Faculdade de Medicina da Universidade do Porto) provided all the financial support for this study.

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Chest

Clinical InvestigationsPulmonary Function Electronic Monitoring Devices: A Randomized Agreement Study

Study objectives

Design, setting, and participants

Measurements

Results

Conclusions

Section snippets

Instruments

Results

Main Findings

Conclusion

J Allergy Clin Immunol

J Allergy Clin Immunol

Chest

BJOG

Chest

Chest

Respir Med

Respir Med

Chest

Chest

Respir Med

J Allergy Clin Immunol

Chest

Chest

Written action plans for asthma: an evidence-based review of the key components

Thorax

Influence of peak expiratory flow monitoring on an asthma self-management education programme

Respir Med

Options for self-management education for adults with asthma

Cochrane Database Syst Rev

Is home monitoring of lung function worthwhile for children with asthma?

Thorax

Usefulness of peak expiratory flow measurements: is it just a matter of instrument accuracy?

Thorax

Clinical Investigations
Pulmonary Function Electronic Monitoring Devices: A Randomized Agreement Study