Effects of Supplemental Oxygen Delivery Via Demand Versus Continuous Flow in Hypoxemic COPD Patients
January 18, 2019 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land
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.
Study Overview
Status
Completed
Conditions
Detailed Description
The Principal Investigator will inform each patient about procedure, content and measurements of the study. It is obligatory that each patient participating in the study gives a written informed consent.
Following an initial incremental shuttle walk test (ISWT) in order to determine the individual maximum capacity, patients will perform three endurance shuttle walk tests (ESWT) at 85% of the maximal pace. In randomized order, patients will complete one ESWT on CF, one on DDL (liquid oxygen) and one on DDC (portable oxygen concentrator). The time between the three ESWTs will be 24 hours in order to give enough time for regeneration. All patients will use the same oxygen devices (CF: Companion 1000 (CE 0050), Chart Industries, Inc. Garfield Heights, Ohio, USA; DD [liquid oxygen]: Caire Spirit 300 (CE 0029), Chart Industries, Inc. Garfield Heights, Ohio, USA), DD [portable concentrator]: Inogen G2, California, USA) and will carry the oxygen device in a backpack. Continuous oxygen flow in liter per minute will be compared to the level of demand delivery (e.g.: 2 l/min CF will be compared to DD level 2).
Study Type
Interventional
Enrollment (Actual)
70
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
-
-
Berchtesgardener Land
-
Schönau, Berchtesgardener Land, Germany, 83471
- Klinikum 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
40 years to 75 years (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: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: COPD patients with delivery order 1, 2, 3
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.
|
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
|
|
EXPERIMENTAL: COPD patients with delivery order 2,3, 1
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.
|
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
|
|
EXPERIMENTAL: COPD patients with delivery order 3, 2, 1
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.
|
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
|
|
EXPERIMENTAL: COPD patients with delivery order 1, 3, 2
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.
|
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
|
|
EXPERIMENTAL: COPD patients with delivery order 2, 1, 3
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.
|
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
|
|
EXPERIMENTAL: COPD patients with delivery order 3, 1, 2
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.
|
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
This oxygen Supplementation is used in special order
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen)
Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breathing frequency
Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
measured by Visionox
|
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
|
Inspiratory capacity
Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
measured by Spiropalm
|
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
|
Heart rate
Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
|
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
|
Walking distance during ESWT
Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
total distance walked during ESWT
|
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
|
dyspnea
Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
assessed by modified Borg scale (0 to 10)
|
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
|
partial pressure of carbon dioxide
Time Frame: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
|
at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (ACTUAL)
April 1, 2016
Primary Completion (ACTUAL)
October 1, 2018
Study Completion (ACTUAL)
October 1, 2018
Study Registration Dates
First Submitted
March 8, 2016
First Submitted That Met QC Criteria
April 15, 2016
First Posted (ESTIMATE)
April 20, 2016
Study Record Updates
Last Update Posted (ACTUAL)
January 22, 2019
Last Update Submitted That Met QC Criteria
January 18, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- O2-Demand-Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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