Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
September 26, 2014
CompletedSeptember 26, 2014
September 1, 2014
5 months
November 18, 2011
January 1, 2014
September 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
50 minutes
Study Arms (3)
1 L/min ; 16 mL
ACTIVE COMPARATORCylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
2 L/min ; 32 mL
ACTIVE COMPARATORCylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
3 L/min ; 48 mL
ACTIVE COMPARATORCylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
Interventions
Pulsed-dose oxygen delivery from an oxygen concentrator
Oxygen delivery from an oxygen cylinder
Eligibility Criteria
You may qualify if:
- Current altitude chamber certification
- Age 18 years - 60 years
You may not qualify if:
- Current upper respiratory infection
- Current symptoms of lower respiratory infection -- productive cough
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cincinnatilead
- United States Air Forcecollaborator
Study Sites (1)
Brooks City Base
San Antonio, Texas, 78235, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Branson
- Organization
- University of Cincinnati
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Branson, MSc RRT
University of Cincinnati
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
November 18, 2011
First Posted
November 22, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2012
Study Completion
September 1, 2012
Last Updated
September 26, 2014
Results First Posted
September 26, 2014
Record last verified: 2014-09