Hypoxia
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
None listed
Sponsors
SterilMed, Inc.
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* Neonatal patient scheduled to undergo cardiac surgery where routine blood draws would be taken * Understand and provide signed parental/guardian consent
Exclusion criteria
* Failure to obtain parental consent * Patients shown to have an adverse reaction to medical tape/adhesive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SpO2 Accuracy Verification Study (ARMS) of ≤ 3% | During Analysis - data were collected anywhere from the beginning of surgery until the completion of the procedure |
Outcome results
None listed