Aviation Portable Oxygen Delivery System

Duke University

Status: Withdrawn

Conditions: Oxygen Delivery Systems at Altitude

Treatments: Device: Integra Pulse Portable- Continuous flow; Device: Integra Pulse Portable- Pneumatic pulsed flow

Study type: Interventional

Funder types: Other

Identifiers

NCT03425409

Pro00087584

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Continuous Flow

Other group

Description:

Oxygen delivery at 4 liters per minute is the standard method

Treatment:

Device: Integra Pulse Portable- Continuous flow

Pneumatic Pulsed Flow

Other group

Description:

Oxygen delivery using test method

Treatment:

Device: Integra Pulse Portable- Pneumatic pulsed flow