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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03365128
Enrollment
0
Registered
2017-12-07
Start date
2025-01-01
Completion date
2025-05-28
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypobaric Hypoxemia

Brief summary

This is a study to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxia.

Detailed description

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.

Interventions

None listed

Sponsors

University of Cincinnati
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Altitude chamber qualified * Previous agreement to be approached regarding altitude chamber research

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Elapsed time during which oxygen saturation by pulse oximetry (SpO2) remains above 90% I15 minutesElapsed 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

Secondary

MeasureTime frameDescription
Amount of oxygen needed to return SpO2 to sea level value I15 minutesAmount of oxygen needed to return subject's SpO2 value to 94% (or higher) after exposure to a simulated altitude of 14,000 feet
Amount of oxygen needed to return SpO2 to sea level value II15 minutesAmount 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
Elapsed time during which SpO2 remains above 90% II15 minutesElapsed 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026