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Oxygen Portable Concentrator During Exercises in Patients With COPD

This study has been completed.
Sponsor:
Information provided by:
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier:
NCT00875719
First received: March 27, 2009
Last updated: February 15, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Device: Oxygen concentrators versus constant flow axygen
Device: oxygen concentrator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:

Primary Outcome Measures:
  • Oxygen Saturation [ Time Frame: One day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Walking Distance [ Time Frame: One day ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: continuous v intermittent Oxygen therapy
intermittent oxygen compared to constant flow oxygen as regards walking distance
 Device: Oxygen concentrators versus constant flow axygen
Each patient performed 2 walking tests, and received oxygen supplementation from a portable concentrator or a liquid oxygen source, in a random order.
Other Name: portable oxygen concentrator
Device: oxygen concentrator
comparison walk distance and saturation with continuous oxygen compared to intermittent oxygen
Other Name: portable concentrator

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875719

Locations
France
Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey
LIMOGES cedex, France, 87042
Sponsors and Collaborators
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Investigators
Principal Investigator: Boris MELLONI, Pr Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
  More Information

No publications provided

Responsible Party: Jean François MUIR - President, ANTADIR
ClinicalTrials.gov Identifier: NCT00875719     History of Changes
Other Study ID Numbers: ANTADIR CMTS OXYGEN 2009
Study First Received: March 27, 2009
Last Updated: February 15, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:
COPD patients with respiratory failure

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Respiratory Insufficiency
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013