Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
14
Brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained.
Hypoxia Lab, UCSF
San Francisco, California, United States
RMSE Compared to CO-oximetry
Root Mean Squared Error between the functional blood oxygen saturation (SpO2) provided by the device under test and the arterial blood oxygen measured with the CO-oximeter.
Time frame: 1 hour
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