Clinical trial NCT05913323: Measuring Lung Mechanics in Patients with COPD Using the REOM Handheld Portable Device
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Copd
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: McGill University
name: Thorasys Thoracic Medical Systems Inc.
First posted: 2023-06-22
Enrollment: 17
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD at the Montreal Chest Institute (MCI) of the McGill University Health Centre (MUHC).

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Males and females aged ≥40 with COPD, former/current smokers with a ≥10 pack-year smoking history.
* Diagnosed with COPD by FEV1/FVC \< 0.7 using standard PFT post-bronchodilator testing, with either 'mild' ('GOLD 1': FEV1 ≥ 80% of predicted value) COPD or 'very severe' ('GOLD 4': FEV1 \< 30% of predicted value) COPD.
* Ability to provide informed consent.

Exclusion Criteria:

* No existing COPD diagnosis
* History of co-morbid asthma
* Current use of home oxygen
* Any acute exacerbation of COPD (AECOPD) experienced within 4 weeks of participation in the study
* Chronic respiratory infection
* Any contraindication to respiratory testing
* Inability to participate in reproducible measurements due to physical or cognitive barrier

Primary outcomes:
measure: Concordance (correlation)
timeFrame: Single-visit study: all tests performed at one single visit.
measure: Agreement
timeFrame: Single-visit study: all tests performed at one single visit.
Secondary outcomes:
measure: Discriminative capacity
timeFrame: Single-visit study: all tests performed at one single visit.
measure: Participant satisfaction and usability experience
timeFrame: Single-visit study: all tests performed at one single visit.
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References: