Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 10
Updated:3/9/2017
Start Date:November 2012
End Date:December 2014

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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.

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 we will be able to establish
correct limits of peripheral pulse oximeter when using the standard and the study sensors.

The investigator hopes to learn the limits of accuracy of currently available and used pulse
oximeters. In children with cyanotic heart disease the "blue sensor" has been found in small
studies to be more accurate compared to the "standard" pulse oximeter.

This study is important as it will provide information as to which pulse oximeter should be
routinely used in children with cyanotic heart disease and to assess which SPO2 even with
blue sensor is borderline and therefore the physician will know to obtain arterial blood
sample for co-oximeter prior to planning important procedures based on a saturation reading.

Inclusion Criteria:

1. Children from LPCH undergoing cardiac catheterization or heart surgery in SUMC or
LPCH respectively

2. Peripheral arterial saturation less than or equal to 90% at time of enrollment

3. weigh between 3-20 kg

4. Less than or equal to 10 years of age

Exclusion Criteria:

1. Lack of consent

2. Greater than 10 years of age

3. Less than 3 kg or more than 20 kg in weight

4. Peripheral arterial saturation greater than 90% at time of enrollment

5. Lack of arterial access
We found this trial at
1
site
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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mi
from
Stanford, CA
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