Effects of Different Oxygen Devices in Hypoxemic COPD Patients

Chronic Obstructive Pulmonary Disease Severe Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998515
• Other study ID #: ACT2016
• Status: Completed
• Phase: N/A
• First received: December 1, 2016
• Last updated: August 16, 2017
• Start date: December 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Severe
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Companion (Liquid oxygen device)

• Activox (concentrator)

Locations

Country	Name	City	State
Germany	Schön Klinik Berchtesgadener Land	Schonau am Konigssee

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken	ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)