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| Name | Class |
|---|---|
| ResMed | INDUSTRY |
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Taken recent literature together, there is a sufficient number of trials investigating the effect of different oxygen devices. However, studies comparing oxygen delivery via portable oxygen concentrator (POC) and liquid oxygen device (LOD) with appropriate exercise testing and sufficient power are missing.
Given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of two different oxygen delivery systems during walking in hypoxemic COPD patients (POC vs. LOD).
The endurance shuttle walk test (ESWT) is well validated for measuring endurance walking capacity in COPD patients with good repeatability. The advantage of this test over the 6MWT is that the ESWT is performed at 85% of the individual maximum which is close to the intensity of typical daily activities. Due to the fact that the ESWT enables us to determine the maximum duration of exercise and to compare values at isotime (at the point of time when the shortest of the 3 ESWTs ends), we use the ESWT as exercise test in our trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESWT order: 1.liquid oxygen, 2. concentrator | Experimental | Patients will start with the endurance shuttle walk test (ESWT) by using supplemental Oxygen from a portable liquid Oxygen device (Companion) and continue on the day after with ESWT by using supplemental Oxygen from a portable concentrator. |
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| ESWT order: 1. concentrator, 2. liquid oxygen | Experimental | Patients will start with the endurance shuttle walk test (ESWT) by using supplemental Oxygen from a concentrator and continue on the day after with ESWT by using supplemental Oxygen from a portable liquid Oxygen device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Companion (Liquid oxygen device) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in oxygen Saturation during endurance shuttle walk test (ESWT) compared between POC (concentrator) and LOD (liquid oxygen) | ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT. | Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Breathing frequency | ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT. | Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schön Klinik Berchtesgadener Land | Schönau am Königssee | 83471 | Germany |
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| Activox (concentrator) | Device |
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| Change in Inspiratory capacity |
ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT. Inspiratory capacity will be measured by a mobile spirometry (SpiroPalm mask). |
| Change from baseline to the individual end of ESWT(until exhaustion, max. 20 minutes) |
| Endurance shuttle walk distance | ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. | at the end of ESWT (until exhaustion, max. 20 minutes) |
| Change in perceived Dyspnea | ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT. Dyspnea will be rated by the Patient on a 10-point Borg scale. | Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes) |
| Change in partial pressure of carbon dioxide | ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT. | Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes) |