Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients

March 28, 2023 updated by: DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing exercise-induced hypoxemia in patients with COPD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

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 Contact

  • Name: Boris MELLONI, Pr
  • Phone Number: +33 1. 56. 81. 40. 60
  • Email: melloni@unilim.fr

Study Locations

  • France
      • Paris, France, 75006
        • Recruiting
        • Fédération ANTADIR
        • Contact:
        • Principal Investigator:
          • Boris MELLONI, Pr

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 on necessity of long term oxygen therapy
  • Able to give their written consent

Exclusion Criteria:

  • Unstable patients with COPD
  • Patients with restrictive respiratory disease
  • Patients with cardiac or neurologic disease contre-indicating the different evaluations

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: oxygen-saving valves
Device: pulse oxygen supplementation devices
oxygen therapy delivered by systems using oxygen-saving valves
Other Names:
  • pulse group
Active Comparator: continuous oxygen supplementation
Device: continuous oxygen
oxygen therapy delivered by continuous liquid oxygen devices
Other Names:
  • continuous group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
oxygen saturation during 6 minutes walking test
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Walking distance during the 6 minutes walking test
Time Frame: 1 day
1 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

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

July 1, 2010

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 11, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVAL- CLIN A00690-39

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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