Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California
San Francisco, California, 94143, United States
NCT Number: NCT04964609
The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the the subject device during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A device intended for use by researchers and healthcare professionals for continuous collection of physiological parameters in home and healthcare settings.
Parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter.
Time frame: Through study completion, 3 months average
SpO2 as measured by the subject device during periods of low motion will be compared to the oxyhemoglobin saturation (SaO2) as measured by direct oximetry with a Radiometer ABL-90 multi-wavelength oximeter
Empatica, Inc.
Industry
Accuracy of Pulse Oximeters With Profound Hypoxia
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