<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/NCT04451733</url>
  </required_header>
  <id_info>
    <org_study_id>INTU_CPRoutcome</org_study_id>
    <nct_id>NCT04451733</nct_id>
  </id_info>
  <brief_title>Effect of ETI Performance on CPR Outcomes</brief_title>
  <official_title>Effect of Endotracheal Intubation Performance on the Outcomes in out-of Hospital Cardiac Arrest Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konkuk University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konkuk University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a clinical observation study based on analysis of video-clip data of cardiopulmonary&#xD;
      resuscitation (CPR) for out-of hospital cardiac arrest (OHCA) in emergency department. Aim of&#xD;
      study is to evaluate effect of the factors relating endotracheal intubation (ETI) on the&#xD;
      outcome of OHCA patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ETI is a standard method for placement of advanced airway during CPR. Frequent attempts or&#xD;
      delayed ETI may affect adversely on the outcomes of OHCA. However, there was no known&#xD;
      detailed data of explaining this issues.&#xD;
&#xD;
      This study tried to evaluate effect of factors of ETI including numbers of trial, time for&#xD;
      ETI trial, interruption time and esophageal intubation during CPR on outcomes of OHCA&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 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>Good Neurologic outcome</measure>
    <time_frame>1 year</time_frame>
    <description>survival with good neurologic status (CPC 1-2) after suffering cardiac arrest</description>
  </primary_outcome>
  <enrollment type="Actual">250</enrollment>
  <condition>Cardiopulmonary Arrest</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endotracheal intubation</intervention_name>
    <description>Perform the endotracheal intubation during CPR</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients in an urban emergency department at a tertiary hospital in Seoul, Korea&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who suffered sudden cardiac arrest and intubated during CPR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  case of requesting the do-not-atempt resuscitation&#xD;
&#xD;
          -  patients who were diagnosed as adavanced cancer&#xD;
&#xD;
          -  cardiac arrest by multiple trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang O Park, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Konkuk University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Emergency Medicine, Konkuk University Medical center</name>
      <address>
        <city>Seoul</city>
        <zip>143-729</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Osman AD, Rahman MA, Lam L, Lin CC, Yeoh M, Judkins S, Pratten N, Moran J, Jones D. Cardiopulmonary resuscitation and endotracheal intubation decisions for adults with advance care directive and resuscitation plans in the emergency department. Australas Emerg Care. 2020 Dec;23(4):247-251. doi: 10.1016/j.auec.2020.05.003. Epub 2020 Jun 11.</citation>
    <PMID>32534981</PMID>
  </reference>
  <reference>
    <citation>Panchal AR, Berg KM, Hirsch KG, Kudenchuk PJ, Del Rios M, Cabanas JG, Link MS, Kurz MC, Chan PS, Morley PT, Hazinski MF, Donnino MW. 2019 American Heart Association Focused Update on Advanced Cardiovascular Life Support: Use of Advanced Airways, Vasopressors, and Extracorporeal Cardiopulmonary Resuscitation During Cardiac Arrest: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2019 Dec 10;140(24):e881-e894. doi: 10.1161/CIR.0000000000000732. Epub 2019 Nov 14.</citation>
    <PMID>31722552</PMID>
  </reference>
  <reference>
    <citation>Newell C, Grier S, Soar J. Airway and ventilation management during cardiopulmonary resuscitation and after successful resuscitation. Crit Care. 2018 Aug 15;22(1):190. doi: 10.1186/s13054-018-2121-y.</citation>
    <PMID>30111343</PMID>
  </reference>
  <reference>
    <citation>Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available. Erratum In: Circulation. 2015 Dec 15;132(24):e385.</citation>
    <PMID>26472995</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Konkuk University Medical Center</investigator_affiliation>
    <investigator_full_name>Sang O, Park</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>intubation</keyword>
  <keyword>Cardiopulmonary Arrest</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</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/NCT04451733
org study id: INTU_CPRoutcome
nct id: NCT04451733
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a clinical observation study based on analysis of video-clip data of cardiopulmonary
      resuscitation (CPR) for out-of hospital cardiac arrest (OHCA) in emergency department. Aim of
      study is to evaluate effect of the factors relating endotracheal intubation (ETI) on the
      outcome of OHCA patients.
ETI is a standard method for placement of advanced airway during CPR. Frequent attempts or
      delayed ETI may affect adversely on the outcomes of OHCA. However, there was no known
      detailed data of explaining this issues.

      This study tried to evaluate effect of factors of ETI including numbers of trial, time for
      ETI trial, interruption time and esophageal intubation during CPR on outcomes of OHCA
      patients.
observational model: Cohort
time perspective: Prospective
measure: Good Neurologic outcome
time frame: 1 year
description: survival with good neurologic status (CPC 1-2) after suffering cardiac arrest
intervention type: Procedure
intervention name: Endotracheal intubation
description: Perform the endotracheal intubation during CPR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Sang O Park, MD, PhD
role: Principal Investigator
affiliation: Konkuk University Medical Center
facility: 
country: Korea, Republic of
citation: Osman AD, Rahman MA, Lam L, Lin CC, Yeoh M, Judkins S, Pratten N, Moran J, Jones D. Cardiopulmonary resuscitation and endotracheal intubation decisions for adults with advance care directive and resuscitation plans in the emergency department. Australas Emerg Care. 2020 Dec;23(4):247-251. doi: 10.1016/j.auec.2020.05.003. Epub 2020 Jun 11.
PMID: 32534981
citation: Panchal AR, Berg KM, Hirsch KG, Kudenchuk PJ, Del Rios M, Cabanas JG, Link MS, Kurz MC, Chan PS, Morley PT, Hazinski MF, Donnino MW. 2019 American Heart Association Focused Update on Advanced Cardiovascular Life Support: Use of Advanced Airways, Vasopressors, and Extracorporeal Cardiopulmonary Resuscitation During Cardiac Arrest: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2019 Dec 10;140(24):e881-e894. doi: 10.1161/CIR.0000000000000732. Epub 2019 Nov 14.
PMID: 31722552
citation: Newell C, Grier S, Soar J. Airway and ventilation management during cardiopulmonary resuscitation and after successful resuscitation. Crit Care. 2018 Aug 15;22(1):190. doi: 10.1186/s13054-018-2121-y.
PMID: 30111343
citation: Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O'Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. No abstract available. Erratum In: Circulation. 2015 Dec 15;132(24):e385.
PMID: 26472995
responsible party type: Principal Investigator
investigator affiliation: Konkuk University Medical Center
investigator full name: Sang O, Park
investigator title: Associate Professor
mesh term: Heart Arrest
sharing ipd: No