Back to resultsOxygen Portable Concentrator During Exercises in Patients With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oxygen concentrators versus constant flow axygen
oxygen concentrator
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD patients with respiratory failure
Eligibility Criteria
Inclusion Criteria:
- COPD with respiratory failure and indication for oxygen supplementation at rest and/or during exercice.
Exclusion Criteria:
- Evolutive heart disease.
- Unability to understand or realize the tests.
- Acute exacerbation during the last month.
Sites / Locations
- Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
continuous v intermittent Oxygen therapy
Arm Description
intermittent oxygen compared to constant flow oxygen as regards walking distance
Outcomes
Primary Outcome Measures
Oxygen Saturation
Secondary Outcome Measures
Walking Distance
Full Information
NCT ID
NCT00875719
First Posted
March 27, 2009
Last Updated
February 15, 2011
Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT00875719
Brief Title
Oxygen Portable Concentrator During Exercises in Patients With COPD
Official Title
Comparing Effectiveness of Oxygen Supplementation From a Portable Concentrator and a Liquid Oxygen Source During Walking Test in COPD Patients With Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial.
Detailed Description
Our primary objective is to compare at rest and during exercise the evolution of oxygen saturation and dyspnea during 6 minutes walking test in patients with COPD receiving oxygen supplementation either with portable concentrators or liquid oxygen in a random order.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD patients with respiratory failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
continuous v intermittent Oxygen therapy
Arm Type
Active Comparator
Arm Description
intermittent oxygen compared to constant flow oxygen as regards walking distance
Intervention Type
Device
Intervention Name(s)
Oxygen concentrators versus constant flow axygen
Other Intervention Name(s)
portable oxygen concentrator
Intervention Description
Each patient performed 2 walking tests, and received oxygen supplementation from a portable concentrator or a liquid oxygen source, in a random order.
Intervention Type
Device
Intervention Name(s)
oxygen concentrator
Other Intervention Name(s)
portable concentrator
Intervention Description
comparison walk distance and saturation with continuous oxygen compared to intermittent oxygen
Primary Outcome Measure Information:
Title
Oxygen Saturation
Time Frame
One day
Secondary Outcome Measure Information:
Title
Walking Distance
Time Frame
One day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD with respiratory failure and indication for oxygen supplementation at rest and/or during exercice.
Exclusion Criteria:
Evolutive heart disease.
Unability to understand or realize the tests.
Acute exacerbation during the last month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris MELLONI, Pr
Organizational Affiliation
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey
City
LIMOGES cedex
ZIP/Postal Code
87042
Country
France
12. IPD Sharing Statement
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Oxygen Portable Concentrator During Exercises in Patients With COPD
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