Aviation Portable Oxygen Delivery System

NCT ID: NCT03425409

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2018-10-01

Brief Summary

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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

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Conditions

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Oxygen Delivery Systems at Altitude

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Continuous Flow

Oxygen delivery at 4 liters per minute is the standard method

Group Type OTHER

Integra Pulse Portable- Continuous flow

Intervention Type DEVICE

4 liters per minute oxygen flow

Pneumatic Pulsed Flow

Oxygen delivery using test method

Group Type OTHER

Integra Pulse Portable- Pneumatic pulsed flow

Intervention Type DEVICE

Oxygen flow determined by test device

Interventions

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Integra Pulse Portable- Continuous flow

4 liters per minute oxygen flow

Intervention Type DEVICE

Integra Pulse Portable- Pneumatic pulsed flow

Oxygen flow determined by test device

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Odessey II Solutions

UNKNOWN

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Moon, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Universtiy Health System

Other Identifiers

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Pro00087584

Identifier Type: -

Identifier Source: org_study_id

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