Brief Summary

Oxygen supplementation has been proven to be effective in hypoxemic COPD patients by increasing oxygenation and reducing dyspnea. In clinical practice there are three common oxygen delivery systems used: continuous oxygen flow (CF), demand oxygen delivery with liquid oxygen (DDL) and demand oxgen delivery with portable oxygen concentrator (DDC). The CF involves considerable wastage of oxygen because oxygen is supplied during in- and exhalation. Demand oxygen delivery saves oxygen and results in a comparable oxygen saturation at rest in COPD patients. However, it is unknown, if oxygen supplementation via demand oxygen delivery is also sufficient during exercise in hypoxemic COPD patients. In addition, it has to be considered that the lower weight of demand oxygen delivery system might enable patients for higher physical activity level and mobility in daily life. The effects of These three oxygen delivery systems shall be investigated by a randomized, controlled cross-over Trial. Every patient has to perform an Incremental Shuttle Walk Test and three Endurance Shuttle Walk Tests with three different oxygen supplementation (via CF, DDL or DDK) in randomized order.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline

Completed

Started Apr 2016

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

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

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Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

March 8, 2016

Completed

24 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed

19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed

Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

2.5 years

First QC Date

March 8, 2016

Last Update Submit

January 18, 2019

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDIncremental Shuttle Walk TestEndurance Shuttle Walk Testoxygen therapy

Outcome Measures

Primary Outcomes (1)

Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen)
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT

Secondary Outcomes (6)

Breathing frequency
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Inspiratory capacity
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Heart rate
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
Walking distance during ESWT
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
dyspnea
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
+1 more secondary outcomes

Study Arms (6)

COPD patients with delivery order 1, 2, 3

EXPERIMENTAL

Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.