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Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects

This study has been completed.
Sponsor:
Collaborator:
United States Air Force
Information provided by (Responsible Party):
Rich Branson, M.D., University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01477450
First received: November 18, 2011
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.


Condition Intervention
Hypobaric Hypoxemia
 Device: Pulse-dose oxygen
Device: Cylinder oxygen delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Reversal of hypoxemia [ Time Frame: 50 minutes ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pulse-dose oxygen
Oxygen delivery in pulsed doses from an oxygen concentrator
 Device: Pulse-dose oxygen
Pulsed-dose oxygen delivery from an oxygen concentrator
Active Comparator: Cylinder oxygen delivery
Oxygen delivery from an oxygen cylinder
 Device: Cylinder oxygen delivery
Oxygen delivery from an oxygen cylinder

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current altitude chamber certification
  • Age 18 years or older

Exclusion Criteria:

  • Current upper respiratory infection
  • Current symptoms of lower respiratory infection -- productive cough
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477450

Locations
United States, Texas
Brooks City Base
San Antonio, Texas, United States
Sponsors and Collaborators
University of Cincinnati
United States Air Force
Investigators
Principal Investigator: Richard Branson, MSc RRT University of Cincinnati
  More Information

No publications provided

Responsible Party: Rich Branson, M.D., Clinical Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01477450     History of Changes
Other Study ID Numbers: Branson-2010-02
Study First Received: November 18, 2011
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Hypobaric hypoxemia
Altitude
Oxygen

Additional relevant MeSH terms:
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013