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Could not obtain regulatory approval
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This is a study to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxia.
The purpose of this study is to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxic events. To do so, the invesitgators propose the following aims:
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| Measure | Description | Time Frame |
|---|---|---|
| Elapsed time during which oxygen saturation by pulse oximetry (SpO2) remains above 90% I | Elapsed time during which subject's SpO2 remains above 90% after initially reaching or exceeding 94% following exposure to a simulated altitude of 14,000 and after receiving pulse-dosed oxygen | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of oxygen needed to return SpO2 to sea level value I | Amount of oxygen needed to return subject's SpO2 value to 94% (or higher) after exposure to a simulated altitude of 14,000 feet | 15 minutes |
| Amount of oxygen needed to return SpO2 to sea level value II |
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Inclusion Criteria:
Exclusion Criteria:
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Normal volunteers aged 18 to 65 years, inclusive
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Amount of oxygen needed to return subject's SpO2 value to 94% (or higher) after (i) reaching SpO2 value of 82-84% or (ii) attaining 85% of maximum predicted heart rate. This is following exercise on a stationary bicycle at a simulated altitude of 10,000 feet |
| 15 minutes |
| Elapsed time during which SpO2 remains above 90% II | Elapsed time during which subject's SpO2 remains above 90% after initially following exposure to a simulated altitude of 14,000 and after initially (i) reaching SpO2 value of 82-84% or (ii) attaining 85% of maximum predicted heart rate. This is following exercise on a stationary bicycle at a simulated altitude of 10,000 feet and after receiving pulse-dosed oxygen. | 15 minutes |