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Efficacy of Two Liquid Oxygen Devices in Deambulation

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: NCT01086891
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : August 30, 2013
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tracking Information
First Submitted Date  ICMJE February 3, 2010
First Posted Date  ICMJE March 15, 2010
Last Update Posted Date August 30, 2013
Study Start Date  ICMJE April 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
To determine the efficacy of correcting desaturation during effort and the acceptance of two different oxygen conserving devices during deambulation,one system with reservoir an another one with oxygen demand valve. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Two Liquid Oxygen Devices in Deambulation
Official Title  ICMJE Efficacy of Two Liquid Oxygen Devices in Deambulation
Brief Summary Some oxygen conserving devices have been developed to diminish oxygen expense. These devices offer optimisation of oxygen therapy for deambulation by improving time autonomy of patients.
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 To Determine the Efficacy of Two Liquid Oxygen Device
Intervention  ICMJE
  • Device: Oxygen conserving devices
    Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated.
    Other Name: Oxygen conserving devices in COPD.
  • Device: Oxygen conserving devices
    Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated
    Other Name: Oxygen conserving devices in interstitial lung disease.
Study Arms  ICMJE
  • Experimental: 1
    Patients with chronic obstructive pulmonary disease who show arterial oxygen desaturation to effort.
    Intervention: Device: Oxygen conserving devices
  • Experimental: 2
    Patients with interstitial lung disease who show arterial oxygen desaturation to effort
    Intervention: Device: Oxygen conserving devices
Publications * Martí S, Pajares V, Morante F, Ramón MA, Lara J, Ferrer J, Güell MR. Are oxygen-conserving devices effective for correcting exercise hypoxemia? Respir Care. 2013 Oct;58(10):1606-13. doi: 10.4187/respcare.02260. Epub 2013 Mar 19.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2012)
60
Original Actual Enrollment  ICMJE
 (submitted: March 12, 2010)
58
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with arterial oxygen desaturation to effort.
  • COPD with TLC > 90%
  • EPID with TLC < 90% and FEV1/FVC > 70%

Exclusion Criteria:

  • Patients with long-term oxygen therapy (LTOT) in deambulation.
  • Not clinically stable during last month.
  • Smokers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01086891
Other Study ID Numbers  ICMJE 07/060/793
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Original Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Santa Creu i Sant Pau Hospital
Current Study Sponsor  ICMJE Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sergi Marti, Doctor H.Vall d'Hebron
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date May 2012

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