Aviation Portable Oxygen Delivery System

Not Applicable

Withdrawn

• Conditions: Oxygen Delivery Systems at Altitude
• Interventions: Device: Integra Pulse Portable- Continuous flow; Device: Integra Pulse Portable- Pneumatic pulsed flow

• Registration Number: NCT03425409
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-07
• Study Start: 2018-09-01
• Status Verified: 2018-10
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• healthy volunteers

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Continuous Flow	Integra Pulse Portable- Continuous flow	Oxygen delivery at 4 liters per minute is the standard method
Pneumatic Pulsed Flow	Integra Pulse Portable- Pneumatic pulsed flow	Oxygen delivery using test method

Primary Outcome Measures

Name	Time	Method
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.