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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: September 24, 2014
Last verified: September 2014
  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
Hypoxemia
Hypobaric Hypoxemia
Device: Pulse-dose oxygen
Device: Cylinder oxygen delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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:
  • Return of Oxygen Saturation to Baseline (Sea Level) Values [ Time Frame: 50 minutes ] [ Designated as safety issue: No ]
    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.


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: 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

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.

  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 - 60 years

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, 78235
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
Results First Received: January 1, 2014
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Hypobaric hypoxemia
Altitude
Oxygen
oxygen concentrator

ClinicalTrials.gov processed this record on November 24, 2014