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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

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.

Condition or disease Intervention/treatment Phase
To Determine the Efficacy of Two Liquid Oxygen Device Device: Oxygen conserving devices Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Two Liquid Oxygen Devices in Deambulation
Study Start Date : April 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: 1
Patients with chronic obstructive pulmonary disease who show arterial oxygen desaturation to effort.
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.

Experimental: 2
Patients with interstitial lung disease who show arterial oxygen desaturation to effort
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.




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086891


Locations
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Spain
Fundacio Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: Sergi Marti, Doctor H.Vall d'Hebron
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01086891    
Other Study ID Numbers: 07/060/793
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: May 2012