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Aviation Portable Oxygen Delivery System

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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Withdrawn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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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