Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease
Completed
Conditions studied: Cyanotic Heart Disease
In brief
Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen saturation, but the gold standard for arterial oxygen saturation is co-oximeter which requires an arterial blood sample. The purpose of this research study is to determine the accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen saturation noted in children with cyanotic heart disease. Hence therapeutic interventions (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be delayed and or inadequate. By doing this study the investigators will be able to establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.
Key facts
- Study ID
- NCT02237014
- Run by
- Stanford University
- People needed
- 53
- Starts
- 2012-11-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2017-03-08
Who can join
Age: any, up to 10. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children from LPCH undergoing cardiac catheterization or heart surgery in SUMC or LPCH respectively
- Peripheral arterial saturation less than or equal to 90% at time of enrollment
- weigh between 3-20 kg
- Less than or equal to 10 years of age
You may not qualify if…
- Lack of consent
- Greater than 10 years of age
- Less than 3 kg or more than 20 kg in weight
- Peripheral arterial saturation greater than 90% at time of enrollment
- Lack of arterial access
Where it is running
- Stanford University Medical Center — Stanford, California, United States
Full record on ClinicalTrials.gov
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