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

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ClinicalTrials.gov Identifier: NCT02237014
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Chandra Ramamoorthy, 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.

Condition or disease
Cyanotic Heart Disease

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.


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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease
Study Start Date : November 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. Accuracy of Peripheral Pulse Oximetry versus Arterial Co-oximeter in Children with Cyanotic Heart Disease [ Time Frame: 2 year ]
    The primary outcome measure is to describe the bias and precision between the Masimo blue sensor and co-oximetry.


Secondary Outcome Measures :
  1. establish correct limits of peripheral pulse oximeter when using the standard and the study sensors. [ Time Frame: 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


Biospecimen Retention:   Samples Without DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with cyanotic heart disease undergoing cardiac catheterization or heart surgery in Stanford University Medical Center(SUMC) or Lucile Packard Children's Hospital(LPCH) respectively with peripheral arterial saturation less than 90% at time of enrollment.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237014


Locations
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United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Chandra Ramamoorthy, MD Department of Anesthesia, Stanford University School of Medicine

Publications of Results:
Other Publications:
Cox P: New pulse oximetry sensors with low saturation accuracy claims-a clinical evaluation [Internet]. Anesthesiology 2007; 107:A1540

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Responsible Party: Chandra Ramamoorthy, Professor, Pediatric Cardiac Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT02237014     History of Changes
Other Study ID Numbers: SU-11062012-11219
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases