Hypobaric HypoxemiaNCT03365128
Enhancing Operability in a Hypobaric Hypoxic Environment With a Small Oxygen Storage System
An observational study of Hypobaric Hypoxemia, run by University of Cincinnati.
Trial summary
This is a study to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypobaric Hypoxemia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 28 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal volunteers aged 18 to 65 years, inclusive
Who may be able to join
- Altitude chamber qualified
- Previous agreement to be approached regarding altitude chamber research
Who cannot join
- -
About this study
This is a study to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxia.
Read the 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:
- Determine the ability of a portable oxygen storage device to reverse hypobaric hypoxemia in volunteers at altitude.
- Determine the duration of time that a single portable oxygen container can maintain normoxia in normal volunteers at altitude.
- Determine the optimum dose and timing of oxygen use to reverse hypobaric hypoxemia.
- Conditions
- Hypobaric Hypoxemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Jan 2025 (estimated)
- Primary completion28 May 2025
- Study completion28 May 2025
Why it stopped: Could not obtain regulatory approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypobaric HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris Blakeman, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365128
- Sponsor's protocol ID
- Blakeman2017
- Status last verified
- May 2025
- First submitted
- 1 Dec 2017
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Operability in a Hypobaric Hypoxic Environment With a Small Oxygen Storage System
- ClinicalTrials.gov ID
- NCT03365128
- Acronym / sponsor ID
- Blakeman2017
- Conditions
- Hypobaric Hypoxemia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Could not obtain regulatory approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the ability of a portable oxygen storage device to reverse hypobaric hypoxemia in volunteers at altitude.
- Determine the duration of time that a single portable oxygen container can maintain normoxia in normal volunteers at altitude.
- Determine the optimum dose and timing of oxygen use to reverse hypobaric hypoxemia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal volunteers aged 18 to 65 years, inclusive
Key inclusion criteria (2 listed)
- Altitude chamber qualified
- Previous agreement to be approached regarding altitude chamber research
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Amount of oxygen needed to return SpO2 to sea level value I
Time frame: 15 minutes
Amount of oxygen needed to return SpO2 to sea level value II
Time frame: 15 minutes
Elapsed time during which SpO2 remains above 90% II
Time frame: 15 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypobaric Hypoxemia, run by University of Cincinnati.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elapsed time during which oxygen saturation by pulse oximetry (SpO2) remains above 90% I (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025; AzTrials last refreshed its copy on 28 Oct 2026.