<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02237014</url>
  </required_header>
  <id_info>
    <org_study_id>SU-11062012-11219</org_study_id>
    <nct_id>NCT02237014</nct_id>
  </id_info>
  <brief_title>Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease</brief_title>
  <official_title>Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen&#xD;
      saturation, but the gold standard for arterial oxygen saturation is co-oximeter which&#xD;
      requires an arterial blood sample. The purpose of this research study is to determine the&#xD;
      accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the&#xD;
      study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against&#xD;
      co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen&#xD;
      saturation noted in children with cyanotic heart disease. Hence therapeutic interventions&#xD;
      (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be&#xD;
      delayed and or inadequate. By doing this study the investigators will be able to establish&#xD;
      correct limits of peripheral pulse oximeter when using the standard and the study sensors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen&#xD;
      saturation, but the gold standard for arterial oxygen saturation is co-oximeter which&#xD;
      requires an arterial blood sample. The purpose of this research study is to determine the&#xD;
      accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the&#xD;
      study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against&#xD;
      co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen&#xD;
      saturation noted in children with cyanotic heart disease. Hence therapeutic interventions&#xD;
      (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be&#xD;
      delayed and or inadequate. By doing this study we will be able to establish correct limits of&#xD;
      peripheral pulse oximeter when using the standard and the study sensors.&#xD;
&#xD;
      The investigator hopes to learn the limits of accuracy of currently available and used pulse&#xD;
      oximeters. In children with cyanotic heart disease the &quot;blue sensor&quot; has been found in small&#xD;
      studies to be more accurate compared to the &quot;standard&quot; pulse oximeter.&#xD;
&#xD;
      This study is important as it will provide information as to which pulse oximeter should be&#xD;
      routinely used in children with cyanotic heart disease and to assess which SPO2 even with&#xD;
      blue sensor is borderline and therefore the physician will know to obtain arterial blood&#xD;
      sample for co-oximeter prior to planning important procedures based on a saturation reading.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of Peripheral Pulse Oximetry versus Arterial Co-oximeter in Children with Cyanotic Heart Disease</measure>
    <time_frame>2 year</time_frame>
    <description>The primary outcome measure is to describe the bias and precision between the Masimo blue sensor and co-oximetry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.</measure>
    <time_frame>2year</time_frame>
    <description>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</description>
  </secondary_outcome>
  <enrollment type="Actual">53</enrollment>
  <condition>Cyanotic Heart Disease</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children with cyanotic heart disease undergoing cardiac catheterization or heart surgery in&#xD;
        Stanford University Medical Center(SUMC) or Lucile Packard Children's Hospital(LPCH)&#xD;
        respectively with peripheral arterial saturation less than 90% at time of enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children from LPCH undergoing cardiac catheterization or heart surgery in SUMC or LPCH&#xD;
             respectively&#xD;
&#xD;
          2. Peripheral arterial saturation less than or equal to 90% at time of enrollment&#xD;
&#xD;
          3. weigh between 3-20 kg&#xD;
&#xD;
          4. Less than or equal to 10 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lack of consent&#xD;
&#xD;
          2. Greater than 10 years of age&#xD;
&#xD;
          3. Less than 3 kg or more than 20 kg in weight&#xD;
&#xD;
          4. Peripheral arterial saturation greater than 90% at time of enrollment&#xD;
&#xD;
          5. Lack of arterial access&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chandra Ramamoorthy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesia, Stanford University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Cox P: New pulse oximetry sensors with low saturation accuracy claims-a clinical evaluation [Internet]. Anesthesiology 2007; 107:A1540</citation>
  </reference>
  <reference>
    <citation>Ross PA, Newth CJ, Khemani RG. Accuracy of pulse oximetry in children. Pediatrics. 2014 Jan;133(1):22-9. doi: 10.1542/peds.2013-1760. Epub 2013 Dec 16.</citation>
    <PMID>24344108</PMID>
  </reference>
  <results_reference>
    <citation>Harris BU, Char DS, Feinstein JA, Verma A, Shiboski SC, Ramamoorthy C. Accuracy of Pulse Oximeters Intended for Hypoxemic Pediatric Patients. Pediatr Crit Care Med. 2016 Apr;17(4):315-20. doi: 10.1097/PCC.0000000000000660.</citation>
    <PMID>26914626</PMID>
  </results_reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>March 7, 2017</last_update_submitted>
  <last_update_submitted_qc>March 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Chandra Ramamoorthy</investigator_full_name>
    <investigator_title>Professor, Pediatric Cardiac Anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02237014
org study id: SU-11062012-11219
nct id: NCT02237014
lead sponsor: 
has dmc: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Accuracy of Peripheral Pulse Oximetry versus Arterial Co-oximeter in Children with Cyanotic Heart Disease
time frame: 2 year
description: The primary outcome measure is to describe the bias and precision between the Masimo blue sensor and co-oximetry.
measure: establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.
time frame: 2year
description: 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
whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 10 Years
healthy volunteers: No
last name: Chandra Ramamoorthy, MD
role: Principal Investigator
affiliation: Department of Anesthesia, Stanford University School of Medicine
facility: 
country: United States
citation: Cox P: New pulse oximetry sensors with low saturation accuracy claims-a clinical evaluation [Internet]. Anesthesiology 2007; 107:A1540
citation: Ross PA, Newth CJ, Khemani RG. Accuracy of pulse oximetry in children. Pediatrics. 2014 Jan;133(1):22-9. doi: 10.1542/peds.2013-1760. Epub 2013 Dec 16.
PMID: 24344108
citation: Harris BU, Char DS, Feinstein JA, Verma A, Shiboski SC, Ramamoorthy C. Accuracy of Pulse Oximeters Intended for Hypoxemic Pediatric Patients. Pediatr Crit Care Med. 2016 Apr;17(4):315-20. doi: 10.1097/PCC.0000000000000660.
PMID: 26914626
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Chandra Ramamoorthy
investigator title: Professor, Pediatric Cardiac Anesthesia
mesh term: Heart Diseases
sharing ipd: Yes