Measuring Lung Mechanics in Patients with COPD Using the REOM Handheld Portable Device
NCT ID: NCT05913323
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
17 participants
OBSERVATIONAL
2023-08-01
2024-08-06
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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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.
Rapid Expiratory Occlusion Monitor (REOM)
Device for which Health Canada approval (ITA Authorization) has been obtained for use in the present study.
Standard oscillometry
tremoflo device-100, Thorasys Thoracic Medical Systems Inc., Montreal, Canada
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.
Rapid Expiratory Occlusion Monitor (REOM)
Device for which Health Canada approval (ITA Authorization) has been obtained for use in the present study.
Standard oscillometry
tremoflo device-100, Thorasys Thoracic Medical Systems Inc., Montreal, Canada
Standard pulmonary function test
Standard-of-care respiratory test.
Interventions
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Rapid Expiratory Occlusion Monitor (REOM)
Device for which Health Canada approval (ITA Authorization) has been obtained for use in the present study.
Standard oscillometry
tremoflo device-100, Thorasys Thoracic Medical Systems Inc., Montreal, Canada
Standard pulmonary function test
Standard-of-care respiratory test.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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McGill University
OTHER
Thorasys Thoracic Medical Systems Inc.
INDUSTRY
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Bryan Ross
Principal Investigator
Locations
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McGill University Health Centre
Montreal, Quebec, Canada
Countries
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Other Identifiers
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2023-9001
Identifier Type: -
Identifier Source: org_study_id
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