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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COMPLETED
12 participants
OBSERVATIONAL
2008-11-30
2008-11-30
Brief Summary
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Detailed Description
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An arterial line will be placed in the radial artery of each subject's right arm, and sensors will be attached to each subject. The subjects will be placed in a semi-supine position and allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip.
Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between 70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide. Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation, based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first 1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be collected via a laptop computer. Concurrent with the end of each blood draw, a marker will be generated on the laptop computers to identify the event.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Healthy; no known blood disorders
* Finger sizes within the sensor specifications
* Minimum 18 years of age
Exclusion Criteria
18 Years
40 Years
ALL
Yes
Sponsors
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Nonin Medical, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Philip E Bickler, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco, Induced Hypoxia Lab
San Francisco, California, United States
Countries
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Other Identifiers
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112008
Identifier Type: -
Identifier Source: org_study_id