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

November 28, 2023 updated by: Chris Blakeman, University of Cincinnati
This is a study to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxia.

Study Overview

Status

Not yet recruiting

Conditions

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

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 15 minutes
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
Time Frame: 15 minutes
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
Time Frame: 15 minutes
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
Time Frame: 15 minutes
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

March 1, 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)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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