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1LDS Hospital and University of Utah, Salt Lake City, UT, USA 2Pfizer Global Research and Development, Groton, CT, USA
ldrjens1{at}ihc.com
Abstract
BackgroundThe objective of the study was to quantify the accuracy and reproducibility of five commercially available pulmonary function test instruments (Collins CPL; Morgan Transflow Test PFT System; SensorMedics Vmax 22D; Jaeger USA Masterscreen Diffusion TP; Medical Graphics Profiler DXTM System) associated with the measurement of spirometry and pulmonary diffusing capacity.
MethodsIn a multifactor, single-center, repeated measures full factorial 90-day study, a pulmonary waveform generator and single-breath carbon monoxide diffusing capacity (DLCO) simulator were used to perform simulations of forced vital capacity (FVC) and DLCO maneuvers. Accuracy was assessed as the difference between observed and simulated values. Reproducibility was determined as the coefficient of variation of all measurements during the study.
ResultsAll instruments demonstrated high degrees of accuracy in the measurement of FVC and forced expired volume in 1 second (FEV1). Overall, the accuracies associated with measurement of peak flow, forced mid expiratory flow (FEF)25- 75% and diffusing capacity were generally lower and more variable among the instruments tested. The coefficients of variation of DLCO measurements over 90 days were higher than those observed for spirometry.
ConclusionsThis study demonstrates the feasibility of assessing the accuracy and reproducibility of modern pulmonary function test instruments using simulation testing. Our results provide an assessment of the component of pulmonary function test accuracy and reproducibility that is due to instrumentation alone.
Key Words: DLCO simulator pulmonary function testing pulmonary waveform generator
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