HypoxemiaNCT01477450
Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
A study testing Pulse-dose oxygen and Cylinder oxygen delivery in people with Hypoxemia and Hypobaric Hypoxemia, run by University of Cincinnati at 1 site in United States.
Trial summary
This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia, Hypobaric Hypoxemia
- What is being tested?
- Pulse-dose oxygen and Cylinder oxygen delivery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current altitude chamber certification
- Age 18 years - 60 years
Who cannot join
- Current upper respiratory infection
- Current symptoms of lower respiratory infection -- productive cough
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.
Read the detailed description
Subjects will be monitored non-invasively with pulse oximetry, end-tidal carbon dioxide, tissue oxygenation and ECG. The mean seal level oxygen saturation will be recorded.Subjects exposed to an altitude of 14,000 feet will experience moderate hypobaric hypoxia. The mean oxygen saturation at this altitude is 83%. Subjects will receive oxygen from both an oxygen concentrator or a cylinder of oxygen following exposure to hypobarism. Oxygen from each source will be increased in 1 liter per minute increments until the oxygen saturation returns to the baseline sea level oxygen saturation.
The oxygen requirement to return oxygen saturation to baseline values will be recorded. The flow from the concentrator and the cylinder will be compared.
- Conditions
- Hypoxemia, Hypobaric Hypoxemia
- Being tested
- Pulse-dose oxygen, Cylinder oxygen delivery
- Keywords
- Hypobaric hypoxemia, Altitude, Oxygen, oxygen concentrator
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse-dose oxygenDevice
Pulsed-dose oxygen delivery from an oxygen concentrator
Cylinder oxygen deliveryDevice
Oxygen delivery from an oxygen cylinder
| Study group | Role | What they receive |
|---|---|---|
| 1 L/min ; 16 mL | Active comparator | Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL) Receives: Device: Pulse-dose oxygen; Device: Cylinder oxygen delivery |
| 2 L/min ; 32 mL | Active comparator | Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL) Receives: Device: Pulse-dose oxygen; Device: Cylinder oxygen delivery |
| 3 L/min ; 48 mL | Active comparator | Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL) Receives: Device: Pulse-dose oxygen; Device: Cylinder oxygen delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of Oxygen Saturation to Baseline (Sea Level) Values
Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.
Measured: 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- United States Air Force
- Responsible party
- Principal investigator, Rich Branson, M.D., University of Cincinnati
- Investigators
- Richard Branson, MSc RRT, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477450
- Sponsor's protocol ID
- Branson-2010-02
- Status last verified
- Sep 2014
- First submitted
- 18 Nov 2011
- Last updated
- 26 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
- ClinicalTrials.gov ID
- NCT01477450
- Acronym / sponsor ID
- Branson-2010-02
- Conditions
- Hypoxemia, Hypobaric Hypoxemia
- Keywords
- Hypobaric hypoxemia, Altitude, Oxygen, oxygen concentrator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- United States Air Force
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Posted 26 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.
Detailed description
Subjects will be monitored non-invasively with pulse oximetry, end-tidal carbon dioxide, tissue oxygenation and ECG. The mean seal level oxygen saturation will be recorded.Subjects exposed to an altitude of 14,000 feet will experience moderate hypobaric hypoxia. The mean oxygen saturation at this altitude is 83%. Subjects will receive oxygen from both an oxygen concentrator or a cylinder of oxygen following exposure to hypobarism. Oxygen from each source will be increased in 1 liter per minute increments until the oxygen saturation returns to the baseline sea level oxygen saturation.
The oxygen requirement to return oxygen saturation to baseline values will be recorded. The flow from the concentrator and the cylinder will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 L/min ; 16 mL | Active comparator | Device: Pulse-dose oxygen, Device: Cylinder oxygen deliveryCylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL) |
| 2 L/min ; 32 mL | Active comparator | Device: Pulse-dose oxygen, Device: Cylinder oxygen deliveryCylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL) |
| 3 L/min ; 48 mL | Active comparator | Device: Pulse-dose oxygen, Device: Cylinder oxygen deliveryCylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Current altitude chamber certification
- Age 18 years - 60 years
Key exclusion criteria (2 listed)
- Current upper respiratory infection
- Current symptoms of lower respiratory infection -- productive cough
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse-dose oxygenPulsed-dose oxygen delivery from an oxygen concentrator | Device | 1 L/min ; 16 mL, 2 L/min ; 32 mL, 3 L/min ; 48 mL |
| Cylinder oxygen deliveryOxygen delivery from an oxygen cylinder | Device | 1 L/min ; 16 mL, 2 L/min ; 32 mL, 3 L/min ; 48 mL |
Primary outcome
Return of Oxygen Saturation to Baseline (Sea Level) Values
Time frame: 50 minutes
Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Branson, MSc RRT principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse-dose oxygen and Cylinder oxygen delivery in people with Hypoxemia and Hypobaric Hypoxemia, run by University of Cincinnati at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 26 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 26 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Return of Oxygen Saturation to Baseline (Sea Level) Values (time frame: 50 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 26 Sep 2014.