Aviation Portable Oxygen Delivery System

Oxygen Delivery Systems at Altitude Clinical Trial

Official title:

Aviation Portable Oxygen Delivery System Based on Pneumatic Pulse Technology

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03425409
• Other study ID #: Pro00087584
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Oxygen Delivery Systems at Altitude

Intervention

Device:
• Integra Pulse Portable- Continuous flow
4 liters per minute oxygen flow
• Integra Pulse Portable- Pneumatic pulsed flow
Oxygen flow determined by test device

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Odessey II Solutions

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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