Aviation Portable Oxygen Delivery System

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.

Study Overview

• Status: Withdrawn
• Conditions: Oxygen Delivery Systems at Altitude
• Intervention / Treatment: Device: Integra Pulse Portable- Continuous flow; Device: Integra Pulse Portable- Pneumatic pulsed flow

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continuous Flow; Oxygen delivery at 4 liters per minute is the standard method	Device: Integra Pulse Portable- Continuous flow; 4 liters per minute oxygen flow
Other: Pneumatic Pulsed Flow; Oxygen delivery using test method	Device: Integra Pulse Portable- Pneumatic pulsed flow; Oxygen flow determined by test device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one minute

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Odessey II Solutions
• Investigators: Principal Investigator: Richard Moon, MD, Duke Universtiy Health System

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Pro00087584

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No