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

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: NCT01477450
Recruitment Status : Completed
First Posted : November 22, 2011
Results First Posted : September 26, 2014
Last Update Posted : September 26, 2014
Sponsor:
Collaborator:
United States Air Force
Information provided by (Responsible Party):
Rich Branson, M.D., University of Cincinnati

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypoxemia Hypobaric Hypoxemia Device: Pulse-dose oxygen Device: Cylinder oxygen delivery Not Applicable

Detailed Description:

Subjects will be monitored non-invasively with pulse oximetry, end-tidal carbon dioxide, tissue oxygenation and ECG. The mean seal level oxygen saturation will be recorded.Subjects exposed to an altitude of 14,000 feet will experience moderate hypobaric hypoxia. The mean oxygen saturation at this altitude is 83%. Subjects will receive oxygen from both an oxygen concentrator or a cylinder of oxygen following exposure to hypobarism. Oxygen from each source will be increased in 1 liter per minute increments until the oxygen saturation returns to the baseline sea level oxygen saturation.

The oxygen requirement to return oxygen saturation to baseline values will be recorded. The flow from the concentrator and the cylinder will be compared.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
Study Start Date : October 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 L/min ; 16 mL
Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
 Device: Pulse-dose oxygen
Pulsed-dose oxygen delivery from an oxygen concentrator

Device: Cylinder oxygen delivery
Oxygen delivery from an oxygen cylinder
Active Comparator: 2 L/min ; 32 mL
Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
 Device: Pulse-dose oxygen
Pulsed-dose oxygen delivery from an oxygen concentrator

Device: Cylinder oxygen delivery
Oxygen delivery from an oxygen cylinder
Active Comparator: 3 L/min ; 48 mL
Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
 Device: Pulse-dose oxygen
Pulsed-dose oxygen delivery from an oxygen concentrator

Device: Cylinder oxygen delivery
Oxygen delivery from an oxygen cylinder


Outcome Measures
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Primary Outcome Measures :
  1. Return of Oxygen Saturation to Baseline (Sea Level) Values [ Time Frame: 50 minutes ]
    Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current altitude chamber certification
  • Age 18 years - 60 years

Exclusion Criteria:

  • Current upper respiratory infection
  • Current symptoms of lower respiratory infection -- productive cough
Contacts and Locations
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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): NCT01477450


Locations
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United States, Texas
Brooks City Base
San Antonio, Texas, United States, 78235
Sponsors and Collaborators
University of Cincinnati
United States Air Force
Investigators
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Principal Investigator: Richard Branson, MSc RRT University of Cincinnati
More Information
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Responsible Party: Rich Branson, M.D., Clinical Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01477450    
Other Study ID Numbers: Branson-2010-02
First Posted: November 22, 2011    Key Record Dates
Results First Posted: September 26, 2014
Last Update Posted: September 26, 2014
Last Verified: September 2014
Keywords provided by Rich Branson, M.D., University of Cincinnati:
Hypobaric hypoxemia
Altitude
Oxygen
oxygen concentrator
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory