<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/NCT03004235</url>
  </required_header>
  <id_info>
    <org_study_id>QATP2978</org_study_id>
    <nct_id>NCT03004235</nct_id>
  </id_info>
  <brief_title>Suspected Cases of Carbon Monoxide Poisoning in the ED</brief_title>
  <official_title>ED Data Collection of Suspected Carbon Monoxide Poisoning</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect non-invasive observational data in suspected or known&#xD;
      carbon monoxide poisoning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    IRB is reviewing all studies at the institution and are on hold&#xD;
  </why_stopped>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">August 8, 2019</completion_date>
  <primary_completion_date type="Actual">August 8, 2019</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>Values from the test device will be compared to the values from co-oximetry to determine the accuracy of the test device</measure>
    <time_frame>Through study completion, an average of 2 years.</time_frame>
  </primary_outcome>
  <enrollment type="Actual">18</enrollment>
  <condition>Carbon Monoxide Poisoning</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Observational data collection</intervention_name>
    <description>Observational data collection</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The participants will be selected based on symptoms in the Emergency Department.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Known or suspected carbon monoxide poisoning&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Miner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hennepin County Medical Center, Minneapolis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>August 8, 2019</last_update_submitted>
  <last_update_submitted_qc>August 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2019</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/NCT03004235
org study id: QATP2978
nct id: NCT03004235
lead sponsor: 
has dmc: No
The purpose of this study is to collect non-invasive observational data in suspected or known
      carbon monoxide poisoning.
observational model: Cohort
time perspective: Prospective
measure: Values from the test device will be compared to the values from co-oximetry to determine the accuracy of the test device
time frame: Through study completion, an average of 2 years.
intervention type: Device
intervention name: Observational data collection
description: Observational data collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Miner, MD
role: Principal Investigator
affiliation: Hennepin County Medical Center, Minneapolis
facility: 
country: United States
responsible party type: Sponsor
mesh term: Poisoning
mesh term: Carbon Monoxide Poisoning
sharing ipd: No