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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Subject | neonatal patients undergoing complex cardiac surgical procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse Oximeter | Device | Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Data are collected anywhere from the beginning of surgery until the completion of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Neonatal patients undergoing complex cardiac surgical procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Hung G Nguyen, MD | UCSF Medical Center at Mission Bay | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center at Mission Bay | San Francisco | California | 94158 | United States |
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