Enhancing Operability in a Hypobaric Hypoxic Environment With a Small Oxygen Storage System

University of Cincinnati

Overview

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: 1. Determine the ability of a portable oxygen storage device to reverse hypobaric hypoxemia in volunteers at altitude. 2. Determine the duration of time that a single portable oxygen container can maintain normoxia in normal volunteers at altitude. 3. Determine the optimum dose and timing of oxygen use to reverse hypobaric hypoxemia.

Study Type

OBSERVATIONAL

Conditions

Hypobaric Hypoxemia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Altitude chamber qualified * Previous agreement to be approached regarding altitude chamber research Exclusion Criteria: \-

Outcomes

Primary Outcomes

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

Time frame: 15 minutes

Secondary Outcomes

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

Time frame: 15 minutes

Amount of oxygen needed to return SpO2 to sea level value II

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

Time frame: 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.

Time frame: 15 minutes

Data from ClinicalTrials.gov

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