Effects of Different Oxygen Devices in Hypoxemic COPD Patients

Study Overview
=================
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.

Official Title
-----------------
Effects of Supplemental Oxygen Delivery Via Portable Oxygen Concentrator (Activox™4L) vs. Liquid Oxygen Device in Hypoxemic COPD Patients - a Non-inferiority Study

Conditions
-----------------
Chronic Obstructive Pulmonary Disease Severe

Intervention / Treatment
-----------------
* Device: Companion (Liquid oxygen device)
* Device: Activox (concentrator)


Participation Criteria
=================
Eligibility Criteria
-----------------
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 exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency Signs of acute exacerbation Any orthopedic or neurological disabilities that prevent patient from walking

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESWT order: 1.liquid oxygen, 2. concentrator<br>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. | Device: Companion (Liquid oxygen device)<br> <br> * Other names: Device: Companion;Device: Activox (concentrator)<br> <br> * Other names: Device: Activox;|
| Experimental: ESWT order: 1. concentrator, 2. liquid oxygen<br>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. | Device: Companion (Liquid oxygen device)<br> <br> * Other names: Device: Companion;Device: Activox (concentrator)<br> <br> * Other names: Device: Activox;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
supplemental oxygen, concentrator, endurance shuttle walk test