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This study will investigate the effects on the SIMEOX technology on static hyperinflation in patients with chronic obstructive pulmonary disease (COPD).
This is a crossover study assessing the short-term effects of SIMEOX and PEP device on static hyperinflation in patients with COPD.
Patients will perform lung function tests (to assess the residual volume and functional residual capacity) before, after and 30 minutes after a 20-min long session of SIMEOX or PEP (depending of randomization).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIMEOX | Active Comparator | Participants will have to perform 20 minutes of SIMEOX. Passive exhalation is required using the SIMEOX, starting from tidal volume and going until achieving residual volume. |
|
| PEP | Active Comparator | Participants will have to perform 20 minutes of PEP. Active exhalation is required using a PEP device, starting from tidal volume and going until achieving residual volume. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIMEOX | Device | SIMEOX is a device generating a succession of gentle depression at the mouth. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in functional residual capacity (FRC) using body plethysmography | FRCpleth before, after and 30 minutes after performing SIMEOX and PEP will be compared. | 15 minutes |
| Change in functional residual capacity (FRC) using helium dilution | FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared. | 5 minutes |
| Change in air trapping | FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared. | 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Brussels | Brussels Capital | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38843595 | Derived | de Macedo JRFF, Aubriot AS, Reychler G, Penelle M, Gohy S, Poncin W. The intermittent intrapulmonary deflation technique for airway clearance in patients with cystic fibrosis: A randomized trial. Respir Med Res. 2024 Nov;86:101094. doi: 10.1016/j.resmer.2024.101094. Epub 2024 Feb 29. | |
| 37917211 | Derived | Ribeiro Fonseca Franco de Macedo J, Reychler G, Poncin W, Liistro G. Effects of the intermittent intrapulmonary deflation technique on expiratory flow limitation: an in vitro study. J Clin Monit Comput. 2024 Feb;38(1):69-75. doi: 10.1007/s10877-023-01093-3. Epub 2023 Nov 2. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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The visits include sessions (test 1 and 2) with SIMEOX or a positive expiratory pressure device (PEP) (chosen according to the subject's randomization) lasting 20 minutes, each followed by a rest period of 30 minutes.
Lung function tests will be performed before, after and 30 minutes after performing the devices (SIMEOX and PEP).
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| PEP |
| Device |
A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration. |
|
| 36810360 | Derived | de Macedo JRFF, Reychler G, Liistro G, Poncin W. Short-Term Effect of Intermittent Intrapulmonary Deflation on Air Trapping in Patients With COPD. Respir Care. 2023 Apr;68(4):478-487. doi: 10.4187/respcare.10398. Epub 2023 Feb 21. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |