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.

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.

Study Overview

• Status: Recruiting
• Conditions: Copd
• Intervention / Treatment: Device: Rapid Expiratory Occlusion Monitor (REOM); Diagnostic test: Standard oscillometry; Diagnostic test: Standard pulmonary function test

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.

• Study Type: Observational
• Enrollment (Estimated): 19

Contacts and Locations

• Study Contact: Name: Bryan A. Ross, MD, FRCPC, MSc (Epi, Physiol); Phone Number: 5149341934; Email: bryan.ross@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McGill University Health Centre
      • Contact: Bryan A Ross, MD, FRCPC, MSc (Epi, Physiol); Phone Number: 514-934-1934; Email: bryan.ross@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD at the Montreal Chest Institute (MCI) of the McGill University Health Centre (MUHC).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD sub-group: GOLD 1 COPD; A secondary objective of the study is to investigate the discriminative capacity of the parameters obtained from the REOM to distinguish between 'mild' and 'very severe' COPD. Thus, there will be a 'mild' (GOLD 1) COPD sub-group.	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.
COPD sub-group: GOLD 4 COPD; A secondary objective of the study is to investigate the discriminative capacity of the parameters obtained from the REOM to distinguish between 'mild' and 'very severe' COPD. Thus, there will be a 'very severe' (GOLD 4) COPD sub-group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Single-visit study: all tests performed at one single visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Single-visit study: all tests performed at one single visit.

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: McGill University; Thorasys Thoracic Medical Systems Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): May 12, 2024
• Study Completion (Estimated): June 12, 2024

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-9001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No