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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 19, 2014