An observational study in Hypoxia, sponsored by Nonin Medical, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-20.
Sponsored by Nonin Medical, Inc · Observational
Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various OEM pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).
The testing is conducted on 12 healthy, consenting, non-smoking subjects in accordance with the IRB approved Protocol. The subjects shall be distributed across both genders and a range of skin tones as equally as practical.
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.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 12 is below the median of 67 across 335 observational studies indexed under Hypoxia.
Browse Hypoxia studies →Nonin Medical, Inc is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy, consenting, non-smoking subjects, 18 years or greater, both genders and a range of skin tones
Exclusion Criteria:
SpO2 Accuracy Verification Study (Arms)of ≤3 between 70 & 100%
Time frame: During Analysis
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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Nonin Medical, Inc