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

Copd Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913323
• Other study ID #: 2023-9001
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: June 12, 2024

Study information

• Verified date: February 2024
• 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
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: June 12, 2024
• Est. primary completion date: May 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Copd

Intervention

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
• Standard pulmonary function test
Standard-of-care respiratory test.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	McGill University, Thorasys Thoracic Medical Systems Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.