Oxygen Delivery Systems at AltitudeNCT03425409
Aviation Portable Oxygen Delivery System
A study testing Integra Pulse Portable- Continuous flow and Integra Pulse Portable- Pneumatic pulsed flow in people with Oxygen Delivery Systems at Altitude, run by Duke University.
Trial summary
This study aims to investigate dose based oxygen delivery vs. continuous flow of oxygen during simulated altitude conditions as would be experienced after a loss of pressure during commercial aircraft flight. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Delivery Systems at Altitude
- What is being tested?
- Integra Pulse Portable- Continuous flow and Integra Pulse Portable- Pneumatic pulsed flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Oct 2018
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
- smoking
- pregnancy
- sickle cell trait
- cardiovascular or pulmonary disease
- significant ear or sinus problems that would prevent equalization during pressure change
- estimated VO2peak <35 mL/kg per minute (males) or <30 mL/kg per minute (females)
About this study
Official title: Aviation Portable Oxygen Delivery System Based on Pneumatic Pulse Technology
This study aims to investigate dose based oxygen delivery vs. continuous flow of oxygen during simulated altitude conditions as would be experienced after a loss of pressure during commercial aircraft flight. Testing will be performed at rest and during light exercise at a simulated altitude of 15,000 feet in a hypobaric chamber. Performance of the two oxygen delivery systems will be compared using oxygen saturation determined by pulse oximetry.
- Conditions
- Oxygen Delivery Systems at Altitude
- Being tested
- Integra Pulse Portable- Continuous flow, Integra Pulse Portable- Pneumatic pulsed flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integra Pulse Portable- Continuous flowDevice
4 liters per minute oxygen flow
Integra Pulse Portable- Pneumatic pulsed flowDevice
Oxygen flow determined by test device
| Study group | Role | What they receive |
|---|---|---|
| Continuous Flow | Other | Oxygen delivery at 4 liters per minute is the standard method Receives: Device: Integra Pulse Portable- Continuous flow |
| Pneumatic Pulsed Flow | Other | Oxygen delivery using test method Receives: Device: Integra Pulse Portable- Pneumatic pulsed flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device performance, as measured by SpO2
The same subject must complete both oxygen delivery system exposures for the data to be used in system performance analysis. Equivalence of the two oxygen delivery systems will be defined as the lack of statistically significant difference (N=20) in SpO2 during the last minute of exercise between the pulse and continuous flow oxygen delivery systems. Average minimum SpO2 over the last minute of the test period will be reported.
Measured: one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen Delivery Systems at AltitudeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Odessey II Solutions
- Responsible party
- Sponsor
- Investigators
- Richard Moon, MD, Principal investigator, Duke Universtiy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425409
- Sponsor's protocol ID
- Pro00087584
- Status last verified
- Oct 2018
- First submitted
- 31 Jan 2018
- Last updated
- 16 Oct 2018
- 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 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aviation Portable Oxygen Delivery System Based on Pneumatic Pulse Technology
- ClinicalTrials.gov ID
- NCT03425409
- Acronym / sponsor ID
- Pro00087584
- Conditions
- Oxygen Delivery Systems at Altitude
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Odessey II Solutions
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 7 Feb 2018 (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 study aims to investigate dose based oxygen delivery vs. continuous flow of oxygen during simulated altitude conditions as would be experienced after a loss of pressure during commercial aircraft flight. Testing will be performed at rest and during light exercise at a simulated altitude of 15,000 feet in a hypobaric chamber. Performance of the two oxygen delivery systems will be compared using oxygen saturation determined by pulse oximetry.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Flow | Other | Device: Integra Pulse Portable- Continuous flowOxygen delivery at 4 liters per minute is the standard method |
| Pneumatic Pulsed Flow | Other | Device: Integra Pulse Portable- Pneumatic pulsed flowOxygen delivery using test method |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (6 listed)
- smoking
- pregnancy
- sickle cell trait
- cardiovascular or pulmonary disease
- significant ear or sinus problems that would prevent equalization during pressure change
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 |
|---|---|---|
| Integra Pulse Portable- Continuous flow4 liters per minute oxygen flow | Device | Continuous Flow |
| Integra Pulse Portable- Pneumatic pulsed flowOxygen flow determined by test device | Device | Pneumatic Pulsed Flow |
Primary outcome
Device performance, as measured by SpO2
Time frame: one minute
The same subject must complete both oxygen delivery system exposures for the data to be used in system performance analysis. Equivalence of the two oxygen delivery systems will be defined as the lack of statistically significant difference (N=20) in SpO2 during the last minute of exercise between the pulse and continuous flow oxygen delivery systems. Average minimum SpO2 over the last minute of the test period will be reported.
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 16 Oct 2018.
- 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.
Richard Moon, MD principal investigator
Duke Universtiy Health System
Questions about this trial
What is this clinical trial studying?
A study testing Integra Pulse Portable- Continuous flow and Integra Pulse Portable- Pneumatic pulsed flow in people with Oxygen Delivery Systems at Altitude, run by Duke University.
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 1 inclusion and 6 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 16 Oct 2018. 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?
Device performance, as measured by SpO2 (time frame: one minute). 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 16 Oct 2018.