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Effects of Different Oxygen Devices in Hypoxemic COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease Severe

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Companion (Liquid oxygen device)
Activox (concentrator)
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease Severe focused on measuring supplemental oxygen, concentrator, endurance shuttle walk test

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schön Klinik Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESWT order: 1.liquid oxygen, 2. concentrator

ESWT order: 1. concentrator, 2. liquid oxygen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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).
Endurance shuttle walk distance
ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity.
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 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.

Full Information

First Posted
December 1, 2016
Last Updated
August 16, 2017
Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT02998515
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
ResMed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease Severe
Keywords
supplemental oxygen, concentrator, endurance shuttle walk test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESWT order: 1.liquid oxygen, 2. concentrator
Arm Type
Experimental
Arm Description
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.
Arm Title
ESWT order: 1. concentrator, 2. liquid oxygen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Companion (Liquid oxygen device)
Other Intervention Name(s)
Device: Companion
Intervention Type
Device
Intervention Name(s)
Activox (concentrator)
Other Intervention Name(s)
Device: Activox
Primary Outcome Measure Information:
Title
Change in oxygen Saturation during endurance shuttle walk test (ESWT) compared between POC (concentrator) and LOD (liquid oxygen)
Description
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.
Time Frame
Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
Secondary Outcome Measure Information:
Title
Change in Breathing frequency
Description
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.
Time Frame
Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
Title
Change in Inspiratory capacity
Description
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).
Time Frame
Change from baseline to the individual end of ESWT(until exhaustion, max. 20 minutes)
Title
Endurance shuttle walk distance
Description
ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity.
Time Frame
at the end of ESWT (until exhaustion, max. 20 minutes)
Title
Change in perceived Dyspnea
Description
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.
Time Frame
Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
Title
Change in partial pressure of carbon dioxide
Description
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.
Time Frame
Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schonau am Konigssee
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Different Oxygen Devices in Hypoxemic COPD Patients

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