The purpose the study is to determine the agreement between the information obtained about lung mechanics (lung function) from the Rapid Expiratory Occlusion Monitor (REOM) handheld portable device with that obtained by conventional oscillometry as well as by pulmonary function testing (PFT), in patients with both 'mild' as well as 'very severe' forms of chronic obstructive pulmonary disease (COPD). This study also intends to study the user experience with this handheld portable device.
The primary objective of this cross-sectional study is to determine the concordance and agreement between the parameters obtained from the REOM, Reo1 and Reo2, and the conventional resistance parameters obtained by the tremoflo oscillometer device (R19 and R5, respectively) in adults with COPD confirmed by diagnostic pulmonary function testing (PFT). The secondary objectives are: 1. To investigate the discriminative capacity of the parameters obtained from the REOM to distinguish between 'mild' and 'very severe' COPD. 2. To collect descriptive information on the participant user experience with the REOM. 3. To determine concordance between the parameters obtained from the REOM and those obtained from the tremoflo oscillometry device with the 'standard' parameters obtained from each participant's standard Pulmonary Function Tests (PFT). Hypothesis: We hypothesize in the adult COPD patient population that the REOM parameter Reo1 and tremoflo device parameter R19 will correlate closely, and that the REOM parameter Reo2 and tremoflo device parameter R5 will correlate closely. We also hypothesize that the REOM, in particular, Reo2, will be able to distinguish between 'mild' and 'very severe' COPD, and that participants will report a positive user experience with the REOM.
Study Type
OBSERVATIONAL
Enrollment
17
Device for which Health Canada approval (ITA Authorization) has been obtained for use in the present study.
tremoflo device-100, Thorasys Thoracic Medical Systems Inc., Montreal, Canada
Standard-of-care respiratory test.
McGill University Health Centre
Montreal, Quebec, Canada
Concordance (correlation)
Correlation will be tested using the Spearman correlation coefficient (r) between REOM-obtained (Reo1 and Reo2) and tremoflo-obtained (R19 and R5) resistance measurements.
Time frame: Single-visit study: all tests performed at one single visit.
Agreement
Agreement will be tested using the Bland-Altman test between REOM-obtained (Reo1 and Reo2) and tremoflo-obtained (R19 and R5) resistance measurements.
Time frame: Single-visit study: all tests performed at one single visit.
Discriminative capacity
The t-test (between 2 independent means) will be used to determine the discriminative capacity of the REOM to distinguish between 'mild' and 'very severe' COPD.
Time frame: Single-visit study: all tests performed at one single visit.
Participant satisfaction and usability experience
Each participant will complete a 'participant satisfaction questionnaire' as well as the validated System Usability Scale (SUS) for each test (REOM, standard oscillometry, pulmonary function test). Data will be presented descriptively.
Time frame: Single-visit study: all tests performed at one single visit.
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