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

Hypobaric Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03365128
• Other study ID #: Blakeman2017
• Status: Not yet recruiting
• Start date: January 1, 2025
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: University of Cincinnati
• Contact: Thomas C Blakeman, MSc
• Phone: 513-558-0514
• Email: blakemtc[@]ucmain.uc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Altitude chamber qualified

• Previous agreement to be approached regarding altitude chamber research

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hypobaric Hypoxemia
• Hypoxia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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