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

Completed

• Conditions: Cyanotic Heart Disease

• Registration Number: NCT02237014
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of Peripheral Pulse Oximetry versus Arterial Co-oximeter in Children with Cyanotic Heart Disease	2 year	The primary outcome measure is to describe the bias and precision between the Masimo blue sensor and co-oximetry.

Secondary Outcome Measures

Name	Time	Method
establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.	2year	The secondary measure was to describe the limits of the blue sensor and standard sensor accuracy as compared with the co-oximeter. If the test sensors consistently have a bias greater than 2 SD from the co-oximeter value at saturations lower than eg., 80 then the recommendation would be that the co-oximetry be used to measure patients saturatioin rather than relying on pulse oximtery alone for clinical decision making

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States