Measuring Lung Mechanics in Patients With COPD Using the REOM Handheld

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Copd

Clinical Trial Details

NCT number	NCT05913323
Study type	Observational
Source	McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact	Bryan A. Ross, MD, FRCPC, MSc (Epi, Physiol)
Phone	5149341934
Email	bryan.ross@mcgill.ca
Status	Recruiting
Phase
Start date	August 1, 2023
Completion date	June 12, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms