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| Name | Class |
|---|---|
| McGill University | OTHER |
| Thorasys Thoracic Medical Systems Inc. | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid Expiratory Occlusion Monitor (REOM) | Device | Device for which Health Canada approval (ITA Authorization) has been obtained for use in the present study. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with COPD at the Montreal Chest Institute (MCI) of the McGill University Health Centre (MUHC).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
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| Standard oscillometry | Diagnostic Test | tremoflo device-100, Thorasys Thoracic Medical Systems Inc., Montreal, Canada |
|
| Standard pulmonary function test | Diagnostic Test | Standard-of-care respiratory test. |
|
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. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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