Effects of Different Oxygen Devices in Hypoxemic COPD Patients

NCT ID: NCT02998515

Last Updated: 2017-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease Severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Companion (Liquid oxygen device)

Intervention Type DEVICE

Activox (concentrator)

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Companion (Liquid oxygen device)

Intervention Type DEVICE

Activox (concentrator)

Intervention Type DEVICE

Interventions

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Companion (Liquid oxygen device)

Intervention Type DEVICE

Activox (concentrator)

Intervention Type DEVICE

Other Intervention Names

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Device: Companion Device: Activox

Eligibility Criteria

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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

* Signs of acute exacerbation
* Any orthopedic or neurological disabilities that prevent patient from walking
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ResMed

INDUSTRY

Sponsor Role collaborator

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

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Klaus Kenn

Head physician of the department of Pneumology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Schön Klinik Berchtesgadener Land

Schönau am Königssee, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ACT2016

Identifier Type: -

Identifier Source: org_study_id

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