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

Primary Purpose

LUNG DISEASES, OBSTRUCTIVE

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pulse oxygen supplementation devices
continuous oxygen
Sponsored by
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for LUNG DISEASES, OBSTRUCTIVE focused on measuring COPD - long term oxygenotherapy, COPD patients with respiratory failure

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fédération ANTADIRRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

oxygen-saving valves

continuous oxygen supplementation

Arm Description

Outcomes

Primary Outcome Measures

oxygen saturation during 6 minutes walking test

Secondary Outcome Measures

Walking distance during the 6 minutes walking test

Full Information

First Posted
August 11, 2010
Last Updated
March 28, 2023
Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT01180803
Brief Title
Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LUNG DISEASES, OBSTRUCTIVE
Keywords
COPD - long term oxygenotherapy, COPD patients with respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oxygen-saving valves
Arm Type
Experimental
Arm Title
continuous oxygen supplementation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
pulse oxygen supplementation devices
Other Intervention Name(s)
pulse group
Intervention Description
oxygen therapy delivered by systems using oxygen-saving valves
Intervention Type
Device
Intervention Name(s)
continuous oxygen
Other Intervention Name(s)
continuous group
Intervention Description
oxygen therapy delivered by continuous liquid oxygen devices
Primary Outcome Measure Information:
Title
oxygen saturation during 6 minutes walking test
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Walking distance during the 6 minutes walking test
Time Frame
1 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boris MELLONI, Pr
Phone
+33 1. 56. 81. 40. 60
Email
melloni@unilim.fr
Facility Information:
Facility Name
Fédération ANTADIR
City
Paris
ZIP/Postal Code
75006
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline DELRIEU, Ph. D
Phone
+33.1.56.81.40.60
Email
delrieu@antadir.com
First Name & Middle Initial & Last Name & Degree
Boris MELLONI, Pr

12. IPD Sharing Statement

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

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