<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/NCT03769740</url>
  </required_header>
  <id_info>
    <org_study_id>047609MP4E</org_study_id>
    <nct_id>NCT03769740</nct_id>
  </id_info>
  <brief_title>Cerebral Oximetry and NIRS in Cardiac Arrest Patients</brief_title>
  <official_title>Cerebral Oximetry and NIRS in Cardiac Arrest Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wayne State University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study to define the role and future applications of cerebral&#xD;
      oximetry in cardiac arrest patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2009</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>ROSC</measure>
    <time_frame>During ED resuscitation</time_frame>
    <description>Return of spontaneous circulation</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cardiac Death</condition>
  <condition>Cardiac Arrest</condition>
  <condition>Emergencies</condition>
  <arm_group>
    <arm_group_label>CPR Group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cerebral Oximetry</intervention_name>
    <description>Non invasive, near infrared spectroscopy cerebral oximetry</description>
    <arm_group_label>CPR Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to the Emergency Department experiencing non-traumatic cardiac arrest&#xD;
        or arriving post non-traumatic cardiac arrest&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Non-traumatic cardiac arrest or post non-traumatic cardiac arrest&#xD;
&#xD;
          -  No purposeful response to verbal or noxious stimuli&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Open head injury/trauma&#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_contact>
    <last_name>Brian J O'Neil, MD</last_name>
    <phone>3139932530</phone>
    <email>boneil@med.wayne.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patrick B Medado</last_name>
    <phone>3135777500</phone>
    <email>pbmedado@med.wayne.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>DMC Detroit Receiving Hospital - Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brian J O'Neil, MD</last_name>
      <phone>313-993-2530</phone>
      <email>boneil@med.wayne.edu</email>
    </contact>
    <investigator>
      <last_name>Brian J O'Neil, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>DMC Sinai-Grace Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Mazzocco, RN</last_name>
      <phone>313-993-2530</phone>
      <email>tmazzocco@med.wayne.edu</email>
    </contact>
    <investigator>
      <last_name>Brian J O'Neil, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wayne State University</investigator_affiliation>
    <investigator_full_name>Brian O'Neil</investigator_full_name>
    <investigator_title>Professor and Chair of Department of Emergency Medicine</investigator_title>
  </responsible_party>
  <keyword>cardiac arrest, cardiac death, CPR, neurologic prognostication, emergency medicine,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03769740
org study id: 047609MP4E
nct id: NCT03769740
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
This is an observational study to define the role and future applications of cerebral
      oximetry in cardiac arrest patients.
observational model: Cohort
time perspective: Prospective
measure: ROSC
time frame: During ED resuscitation
description: Return of spontaneous circulation
arm group label: CPR Group
intervention type: Device
intervention name: Cerebral Oximetry
description: Non invasive, near infrared spectroscopy cerebral oximetry
arm group label: CPR Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian J O'Neil, MD
phone: 3139932530
email: boneil@med.wayne.edu
last name: Patrick B Medado
phone: 3135777500
email: pbmedado@med.wayne.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wayne State University
investigator full name: Brian O'Neil
investigator title: Professor and Chair of Department of Emergency Medicine
mesh term: Heart Arrest
mesh term: Emergencies
mesh term: Death
sharing ipd: Undecided