Effects of Different Oxygen Devices in Hypoxemic COPD Patients

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease Severe
• Interventions: Device: Companion (Liquid oxygen device); Device: Activox (concentrator)

• Registration Number: NCT02998515
• Lead Sponsor: Schön Klinik Berchtesgadener Land

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-20
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ESWT order: 1.liquid oxygen, 2. concentrator	Activox (concentrator)	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.
ESWT order: 1.liquid oxygen, 2. concentrator	Companion (Liquid oxygen device)	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.
ESWT order: 1. concentrator, 2. liquid oxygen	Activox (concentrator)	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.
ESWT order: 1. concentrator, 2. liquid oxygen	Companion (Liquid oxygen device)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.
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.

Trial Locations

Locations (1)

Schön Klinik Berchtesgadener Land; 🇩🇪 Schonau am Konigssee, Germany