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.

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

SterilMed, Inc.

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Dec 3, 2010
Registry last updated: Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed