Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Hypoxia

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.

• Study Type: Observational
• Enrollment (Actual): 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonatal children undergoing complex cardiac surgical procedures.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: SterilMed, Inc.
• Investigators: Principal Investigator: Greg Stratmann, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: December 1, 2010
• First Submitted That Met QC Criteria: December 2, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Estimate): December 3, 2010
• Last Update Submitted That Met QC Criteria: December 2, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: STER01P