Chronic Obstructive Pulmonary Disease Severe
Conditions
Keywords
supplemental oxygen, concentrator, endurance shuttle walk test
Brief summary
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.
Interventions
DEVICECompanion (Liquid oxygen device)
DEVICEActivox (concentrator)
Sponsors
ResMed
Schön Klinik Berchtesgadener Land
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise (paO2\<60mmHg) * Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL) * Written informed consent
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in oxygen Saturation during endurance shuttle walk test (ESWT) compared between POC (concentrator) and LOD (liquid oxygen) | Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Breathing frequency | Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes) | 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 in Inspiratory capacity | Change from baseline to the individual end of ESWT(until exhaustion, max. 20 minutes) | 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). |
| Endurance shuttle walk distance | at the end of ESWT (until exhaustion, max. 20 minutes) | ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. |
| Change in perceived Dyspnea | Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes) | 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 in partial pressure of carbon dioxide | Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes) | 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. |
Countries
Germany
Outcome results
None listed