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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01180803
Recruitment Status : Unknown
Verified November 2017 by DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche.
Recruitment status was:  Recruiting
First Posted : August 12, 2010
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Tracking Information
First Submitted Date  ICMJE August 11, 2010
First Posted Date  ICMJE August 12, 2010
Last Update Posted Date November 22, 2017
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
oxygen saturation during 6 minutes walking test [ Time Frame: 1 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
Walking distance during the 6 minutes walking test [ Time Frame: 1 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE LUNG DISEASES, OBSTRUCTIVE
Intervention  ICMJE
  • Device: pulse oxygen supplementation devices
    oxygen therapy delivered by systems using oxygen-saving valves
    Other Name: pulse group
  • Device: continuous oxygen
    oxygen therapy delivered by continuous liquid oxygen devices
    Other Name: continuous group
Study Arms  ICMJE
  • Experimental: oxygen-saving valves
    Intervention: Device: pulse oxygen supplementation devices
  • Active Comparator: continuous oxygen supplementation
    Intervention: Device: continuous oxygen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 11, 2010)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01180803
Other Study ID Numbers  ICMJE EVAL- CLIN A00690-39
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Study Sponsor  ICMJE Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP