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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014