<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/NCT02262195</url>
  </required_header>
  <id_info>
    <org_study_id>QATP2338</org_study_id>
    <nct_id>NCT02262195</nct_id>
  </id_info>
  <brief_title>Dysfunctional Hemoglobin</brief_title>
  <official_title>Dysfunctional Hemoglobin Pulse Co-ox</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nonin Medical, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nonin Medical, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine if a new pulse oximeter accurately detects&#xD;
      carboxyhemoglobin and methemoglobin when intentionally increased in the blood.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry</measure>
    <time_frame>4 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate methemoglobin over the range of 0-15 percent as assessed by co-oximetry</measure>
    <time_frame>4 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin</measure>
    <time_frame>4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine oxygen saturation accuracy in conditions of elevated methemoglobin</measure>
    <time_frame>4 hours</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Elevated Levels of Carboxyhemoglobin and Methemoglobin</condition>
  <arm_group>
    <arm_group_label>Carboxyhemoglobin</arm_group_label>
    <description>Induced carboxyhemoglobin levels up tp 15 percent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methemoglobin</arm_group_label>
    <description>Induced methemoglobin levels up to 15 percent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Elevated levels of carboxyhemoglobin</intervention_name>
    <description>Comparison of pulse co-oximeters</description>
    <arm_group_label>Carboxyhemoglobin</arm_group_label>
    <arm_group_label>Methemoglobin</arm_group_label>
    <other_name>Elevated levels of methemoglobin</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy Adult volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects does not have significant medical problems&#xD;
&#xD;
          -  Subject is willing to provide written informed consent&#xD;
&#xD;
          -  Subject is between 18 and 45 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a BMI greater than 31&#xD;
&#xD;
          -  Has had any relevant injury at the sensor location site&#xD;
&#xD;
          -  Has deformities or abnormalities that may prevent proper application of the device&#xD;
             under test&#xD;
&#xD;
          -  Has a known respiratory condition&#xD;
&#xD;
          -  Is currently a smoker&#xD;
&#xD;
          -  Has a known heart or cardiovascular condition&#xD;
&#xD;
          -  Is currently pregnant&#xD;
&#xD;
          -  Is female and actively trying to get pregnant&#xD;
&#xD;
          -  Has a clotting disorder&#xD;
&#xD;
          -  Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell&#xD;
             anemia, inherited or congenital methemoglobinemia)&#xD;
&#xD;
          -  The subject has a COHb greater than 3% or MetHb greater than 2%&#xD;
&#xD;
          -  Has taken blood thinners or medication with aspirin within the last 24 hours&#xD;
&#xD;
          -  Has unacceptable collateral circulation from the ulnar artery&#xD;
&#xD;
          -  Has donated more than 300 mL of blood within one month prior to start of study&#xD;
&#xD;
          -  Is unwilling or unable to provide written informed consent to participate in the study&#xD;
&#xD;
          -  Is unwilling or unable to comply with the study procedures&#xD;
&#xD;
          -  Has another health condition which in the opinion of the principal investigator makes&#xD;
             him/her unsuitable for testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Phillip E Bickler, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>April 20, 2015</last_update_submitted>
  <last_update_submitted_qc>April 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02262195
org study id: QATP2338
nct id: NCT02262195
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to determine if a new pulse oximeter accurately detects
      carboxyhemoglobin and methemoglobin when intentionally increased in the blood.
observational model: Cohort
time perspective: Prospective
measure: Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry
time frame: 4 hours
measure: Evaluate methemoglobin over the range of 0-15 percent as assessed by co-oximetry
time frame: 4 hours
measure: Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin
time frame: 4 hours
measure: Determine oxygen saturation accuracy in conditions of elevated methemoglobin
time frame: 4 hours
arm group label: Carboxyhemoglobin
description: Induced carboxyhemoglobin levels up tp 15 percent.
arm group label: Methemoglobin
description: Induced methemoglobin levels up to 15 percent.
intervention type: Other
intervention name: Elevated levels of carboxyhemoglobin
description: Comparison of pulse co-oximeters
arm group label: Carboxyhemoglobin
arm group label: Methemoglobin
other name: Elevated levels of methemoglobin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Phillip E Bickler, MD, PhD
role: Principal Investigator
affiliation: University of San Francisco
facility: 
country: United States
responsible party type: Sponsor