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

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

Study Overview

• Status: Withdrawn
• Conditions: Hypobaric Hypoxemia

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.

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Normal volunteers aged 18 to 65 years, inclusive

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: Blakeman2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No