Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

SterilMed, Inc.4 enrolled

Overview

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

Conditions

Hypoxia

Eligibility

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

SpO2 Accuracy Verification Study (ARMS) of ≤ 3%

Time frame: During Analysis - data were collected anywhere from the beginning of surgery until the completion of the procedure

Data from ClinicalTrials.gov

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