Effects of Different Oxygen Devices in Hypoxemic COPD Patients

August 16, 2017 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schonau am Konigssee, Germany, 83471
        • Schön Klinik Berchtesgadener Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ESWT order: 1.liquid oxygen, 2. 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.
Device: Companion (Liquid oxygen device)
Other Names:
  • Device: Companion
Device: Activox (concentrator)
Other Names:
  • Device: Activox
EXPERIMENTAL: ESWT order: 1. concentrator, 2. liquid oxygen
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)
Other Names:
  • Device: Companion
Device: Activox (concentrator)
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)
Time Frame: 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 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
Time Frame: 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 from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
Change in Inspiratory capacity
Time Frame: 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 from baseline to the individual end of ESWT(until exhaustion, max. 20 minutes)
Endurance shuttle walk distance
Time Frame: 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.
at the end of ESWT (until exhaustion, max. 20 minutes)
Change in perceived Dyspnea
Time Frame: 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 from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
Change in partial pressure of carbon dioxide
Time Frame: 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 from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schön Klinik Berchtesgadener Land

Collaborators

ResMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (ESTIMATE)

December 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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