Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
Primary Purpose
Hypoxemia, Hypobaric Hypoxemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulse-dose oxygen
Cylinder oxygen delivery
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxemia focused on measuring Hypobaric hypoxemia, Altitude, Oxygen, oxygen concentrator
Eligibility 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
Sites / Locations
- Brooks City Base
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1 L/min ; 16 mL
2 L/min ; 32 mL
3 L/min ; 48 mL
Arm Description
Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
Outcomes
Primary Outcome Measures
Return of Oxygen Saturation to Baseline (Sea Level) Values
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01477450
First Posted
November 18, 2011
Last Updated
September 24, 2014
Sponsor
University of Cincinnati
Collaborators
United States Air Force
1. Study Identification
Unique Protocol Identification Number
NCT01477450
Brief Title
Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
Official Title
Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
United States Air Force
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia, Hypobaric Hypoxemia
Keywords
Hypobaric hypoxemia, Altitude, Oxygen, oxygen concentrator
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 L/min ; 16 mL
Arm Type
Active Comparator
Arm Description
Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
Arm Title
2 L/min ; 32 mL
Arm Type
Active Comparator
Arm Description
Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
Arm Title
3 L/min ; 48 mL
Arm Type
Active Comparator
Arm Description
Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
Intervention Type
Device
Intervention Name(s)
Pulse-dose oxygen
Intervention Description
Pulsed-dose oxygen delivery from an oxygen concentrator
Intervention Type
Device
Intervention Name(s)
Cylinder oxygen delivery
Intervention Description
Oxygen delivery from an oxygen cylinder
Primary Outcome Measure Information:
Title
Return of Oxygen Saturation to Baseline (Sea Level) Values
Description
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.
Time Frame
50 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Branson, MSc RRT
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooks City Base
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78235
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
We'll reach out to this number within 24 hrs