Clinical trial NCT02998515: Effects of Different Oxygen Devices in Hypoxemic COPD Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Severe
Keywords: supplemental oxygen
concentrator
endurance shuttle walk test
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: ResMed
First posted: 2016-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in oxygen Saturation during endurance shuttle walk test (ESWT) compared between POC (concentrator) and LOD (liquid oxygen)
timeFrame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
Secondary outcomes:
measure: Change in Breathing frequency
timeFrame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
measure: Change in Inspiratory capacity
timeFrame: Change from baseline to the individual end of ESWT(until exhaustion, max. 20 minutes)
measure: Endurance shuttle walk distance
timeFrame: at the end of ESWT (until exhaustion, max. 20 minutes)
measure: Change in perceived Dyspnea
timeFrame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
measure: Change in partial pressure of carbon dioxide
timeFrame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
Other outcomes:
Locations:
city: Schonau am Konigssee
country: Germany
facility: Schön Klinik Berchtesgadener Land
Study officials:
References: