Cardiac Surgery
Conditions
Brief summary
Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.
Detailed description
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.
Interventions
DEVICEPulse Oximeter
Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate.
Sponsors
University of California, San Francisco
Taiwan Aulisa Medical Devices Technologies, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Years
Healthy volunteers
No
Inclusion criteria
* Neonates scheduled to undergo cardiac surgery where routine blood draws would be taken * Consent signed by at least one legal guardian
Exclusion criteria
* Presence of any skin irritation or breakdown on the foot * Foot impediments which would preclude proper placement of the sensor * Clinical condition precluding the use of adhesive materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of Pulse Oximeter Sensor in Neonates | Data are collected anywhere from the beginning of surgery until the completion of the procedure | Pulse Oximeters - Premarket Notifications Submissions \[510(k)s\] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013) |
Countries
United States
Outcome results
None listed