NCT05913323

Measuring Lung Mechanics in Patients with COPD Using the REOM Handheld Portable Device

Measuring Lung Mechanics in Patients with Chronic Obstructive Pulmonary Disease (COPD) Using the Rapid Expiratory Occlusion Method (REOM) Handheld Portable Oscillometer: a Cross-Sectional Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Copd

Interventions

Type	Name	Description
DEVICE	Rapid Expiratory Occlusion Monitor (REOM)	Device for which Health Canada approval (ITA Authorization) has been obtained for use in the present study.
DIAGNOSTIC_TEST	Standard oscillometry	tremoflo device-100, Thorasys Thoracic Medical Systems Inc., Montreal, Canada
DIAGNOSTIC_TEST	Standard pulmonary function test	Standard-of-care respiratory test.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-08-06
• Completion: 2024-08-06
• First posted: 2023-06-22
• Last updated: 2024-09-26

Locations

1 site across 1 country: Canada