Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.
Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.
Study Type
OBSERVATIONAL
Enrollment
15
Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate.
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Performance of Pulse Oximeter Sensor in Neonates
Pulse Oximeters - Premarket Notifications Submissions \[510(k)s\] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)
Time frame: Data are collected anywhere from the beginning of surgery until the completion of the procedure
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