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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypoxemia, Hypobaric Hypoxemia

Intervention / Treatment
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* Device: Pulse-dose oxygen
* Device: Cylinder oxygen delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 L/min ; 16 mL<br>Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL) | Device: Pulse-dose oxygen<br>* Pulsed-dose oxygen delivery from an oxygen concentrator<br>Device: Cylinder oxygen delivery<br>* Oxygen delivery from an oxygen cylinder<br>|
| Active Comparator: 2 L/min ; 32 mL<br>Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL) | Device: Pulse-dose oxygen<br>* Pulsed-dose oxygen delivery from an oxygen concentrator<br>Device: Cylinder oxygen delivery<br>* Oxygen delivery from an oxygen cylinder<br>|
| Active Comparator: 3 L/min ; 48 mL<br>Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL) | Device: Pulse-dose oxygen<br>* Pulsed-dose oxygen delivery from an oxygen concentrator<br>Device: Cylinder oxygen delivery<br>* Oxygen delivery from an oxygen cylinder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypobaric hypoxemia, Altitude, Oxygen, oxygen concentrator