Oxygen Portable Concentrator During Exercises in Patients With COPD

February 15, 2011 updated by: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Comparing Effectiveness of Oxygen Supplementation From a Portable Concentrator and a Liquid Oxygen Source During Walking Test in COPD Patients With Respiratory Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

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

  • France
      • LIMOGES cedex, France, 87042
        • Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey

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

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • portable oxygen concentrator
Device: oxygen concentrator
comparison walk distance and saturation with continuous oxygen compared to intermittent oxygen
Other Names:
  • portable concentrator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oxygen Saturation
Time Frame: One day
One day

Secondary Outcome Measures

Outcome Measure
Time Frame
Walking Distance
Time Frame: One day
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Investigators

  • Principal Investigator: Boris MELLONI, Pr, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

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

February 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

April 3, 2009

Study Record Updates

Last Update Posted (Estimate)

February 16, 2011

Last Update Submitted That Met QC Criteria

February 15, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANTADIR CMTS OXYGEN 2009

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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