Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2018-09-01
2018-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DEVICE_FEASIBILITY
NONE
Study Groups
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Continuous Flow
Oxygen delivery at 4 liters per minute is the standard method
Integra Pulse Portable- Continuous flow
4 liters per minute oxygen flow
Pneumatic Pulsed Flow
Oxygen delivery using test method
Integra Pulse Portable- Pneumatic pulsed flow
Oxygen flow determined by test device
Interventions
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Integra Pulse Portable- Continuous flow
4 liters per minute oxygen flow
Integra Pulse Portable- Pneumatic pulsed flow
Oxygen flow determined by test device
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
40 Years
ALL
Yes
Sponsors
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Odessey II Solutions
UNKNOWN
Duke University
OTHER
Responsible Party
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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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