NCT02998515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

December 1, 2016

Last Update Submit

August 16, 2017

Conditions

Chronic Obstructive Pulmonary Disease Severe

Keywords

supplemental oxygenconcentratorendurance shuttle walk test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in Breathing frequency

    Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)

  • Change in Inspiratory capacity

    Change from baseline to the individual end of ESWT(until exhaustion, max. 20 minutes)

  • Endurance shuttle walk distance

    at the end of ESWT (until exhaustion, max. 20 minutes)

  • Change in perceived Dyspnea

    Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)

  • Change in partial pressure of carbon dioxide

    Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)

Study Arms (2)

ESWT order: 1.liquid oxygen, 2. concentrator

EXPERIMENTAL

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)Device: Activox (concentrator)

ESWT order: 1. concentrator, 2. liquid oxygen

EXPERIMENTAL

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)Device: Activox (concentrator)

Interventions

Companion (Liquid oxygen device)DEVICE
Also known as: Device: Companion
ESWT order: 1. concentrator, 2. liquid oxygenESWT order: 1.liquid oxygen, 2. concentrator
Activox (concentrator)DEVICE
Also known as: Device: Activox
ESWT order: 1. concentrator, 2. liquid oxygenESWT order: 1.liquid oxygen, 2. concentrator

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Signs of acute exacerbation
  • Any orthopedic or neurological disabilities that prevent patient from walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head physician of the department of Pneumology

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 20, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

DE(1)