Oxygen Delivery Systems at Altitude
Conditions
Brief 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. 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.
Interventions
DEVICEIntegra Pulse Portable- Continuous flow
4 liters per minute oxygen flow
DEVICEIntegra Pulse Portable- Pneumatic pulsed flow
Oxygen flow determined by test device
Sponsors
Odessey II Solutions
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy volunteers
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device performance, as measured by SpO2 | 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. |
Outcome results
None listed