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

Not Applicable

Completed

• Conditions: Hypobaric Hypoxemia; Hypoxemia
• Interventions: Device: Pulse-dose oxygen; Device: Cylinder oxygen delivery

• Registration Number: NCT01477450
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Primary Completion: 2012-03
• Study Completion: 2012-09
• Results First Submitted: 2014-01-01
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-24
• Last Update Submitted: 2014-09-24
• Results First Posted: 2014-09-26
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 L/min ; 32 mL	Pulse-dose oxygen	Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
2 L/min ; 32 mL	Cylinder oxygen delivery	Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)
1 L/min ; 16 mL	Cylinder oxygen delivery	Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)
3 L/min ; 48 mL	Pulse-dose oxygen	Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
3 L/min ; 48 mL	Cylinder oxygen delivery	Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)
1 L/min ; 16 mL	Pulse-dose oxygen	Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)

Primary Outcome Measures

Name	Time	Method
Return of Oxygen Saturation to Baseline (Sea Level) Values	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.

Trial Locations

Locations (1)

Brooks City Base; 🇺🇸 San Antonio, Texas, United States