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

Sponsor
University of Cincinnati (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03365128
Collaborator
(none)
20
Enrollment
6.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Enhancing Operability in a Hypobaric Hypoxic Environment With a Small Oxygen Storage System
    Anticipated Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Feb 28, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Elapsed time during which oxygen saturation by pulse oximetry (SpO2) remains above 90% I [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

    Secondary Outcome Measures

    1. Amount of oxygen needed to return SpO2 to sea level value I [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

    2. Amount of oxygen needed to return SpO2 to sea level value II [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

    3. Elapsed time during which SpO2 remains above 90% II [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Altitude chamber qualified

    • Previous agreement to be approached regarding altitude chamber research

    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Cincinnati

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chris Blakeman, Instructor, University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT03365128
    Other Study ID Numbers:
    • Blakeman2017
    First Posted:
    Dec 7, 2017
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypoxia

    Study Results

    No Results Posted as of Feb 15, 2022