<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/NCT03030833</url>
  </required_header>
  <id_info>
    <org_study_id>QATP3040</org_study_id>
    <nct_id>NCT03030833</nct_id>
  </id_info>
  <brief_title>Dysfunctional Hemoglobin Pulse Oximetry</brief_title>
  <official_title>Dysfunctional Hemoglobin Pulse Oximeter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nonin Medical, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nonin Medical, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess device performance in the presence of carbon monoxide.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">April 30, 2017</completion_date>
  <primary_completion_date type="Actual">April 30, 2017</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>Carboxyhemoglobin accuracy</measure>
    <time_frame>Through study completion, an average of 3 months.</time_frame>
    <description>Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.</description>
  </primary_outcome>
  <enrollment type="Actual">36</enrollment>
  <condition>Carbon Monoxide Poisoning</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulse Oximeter</intervention_name>
    <description>Comparison of pulse oximetry to blood gas analyzer.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy male and females.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject is male or female.&#xD;
&#xD;
          -  The subject is of any racial or ethnic group.&#xD;
&#xD;
          -  The subject is between 18 years and 50 years of age (self-reported).&#xD;
&#xD;
          -  The subject does not have significant medical problems (self-reported).&#xD;
&#xD;
          -  The subject is willing to provide written informed consent and is willing and able to&#xD;
             comply with study procedures.&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
          -  Has a BMI greater than 30.0 (calculated from self-reported weight and height).&#xD;
&#xD;
          -  Has had any relevant injury at the sensor location site (self-reported).&#xD;
&#xD;
          -  Has a deformity or abnormalities that may prevent proper application of the device&#xD;
             under test (based on visual inspection).&#xD;
&#xD;
          -  Has a known respiratory condition (self-reported).&#xD;
&#xD;
          -  Is currently a smoker (self-reported).&#xD;
&#xD;
          -  Has a known heart or cardiovascular condition (self-reported).&#xD;
&#xD;
          -  Is currently pregnant (positive serum pregnancy test at screening visit or positive&#xD;
             urine POC test on day of study).&#xD;
&#xD;
          -  Is female and actively trying to get pregnant (self-reported).&#xD;
&#xD;
          -  Has a clotting disorder (self-reported).&#xD;
&#xD;
          -  Has Raynaud's Disease (self-reported).&#xD;
&#xD;
          -  Is known to have anemia (hemoglobin value below lower range of normal for gender)&#xD;
&#xD;
          -  Is known to have a hemoglobinopathy such as sickle-cell anemia or thalassemia&#xD;
             (abnormal hemoglobin electrophoresis).&#xD;
&#xD;
          -  Is known to have a inherited or congenital methemoglobinemia (self-reported).&#xD;
&#xD;
          -  Has unacceptable collateral circulation from the ulnar artery (based on exam).&#xD;
&#xD;
          -  Is unwilling or unable to provide written informed consent to participate in the&#xD;
             study.&#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>50 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>David B MacLeod, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HPPL Duke Univeristy</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poisoning</mesh_term>
    <mesh_term>Carbon Monoxide Poisoning</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03030833
org study id: QATP3040
nct id: NCT03030833
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of the study is to assess device performance in the presence of carbon monoxide.
observational model: Cohort
time perspective: Prospective
measure: Carboxyhemoglobin accuracy
time frame: Through study completion, an average of 3 months.
description: Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.
intervention type: Device
intervention name: Pulse Oximeter
description: Comparison of pulse oximetry to blood gas analyzer.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
last name: David B MacLeod, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Poisoning
mesh term: Carbon Monoxide Poisoning
sharing ipd: No