<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/NCT03256019</url>
  </required_header>
  <id_info>
    <org_study_id>CPRIntuVLvsDL</org_study_id>
    <nct_id>NCT03256019</nct_id>
  </id_info>
  <brief_title>Compare Outcomes of CPR Between the Video-laryngoscopy (VL) Users and the Direct-laryngoscopy (DL) Users</brief_title>
  <official_title>Improvement of Recovery of Spontaneous Circulation and Survival Using the Video-laryngoscopy for out-of Hospital Cardiac Arrest Patient</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 study based on the analysis of video-clip data of cardiopulmonary&#xD;
      resuscitation (CPR) and clinical data for out of hospital cardiac arrest patients between&#xD;
      2011 and 2015. Aim of study is to compare the endotracheal intubation performance and CPR&#xD;
      outcomes between videolaryngoscopy (VL) and direct laryngoscopy (DL) users.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endotracheal intubation (ETI) has been considered to be the best method of airway management&#xD;
      during cardiopulmonary resuscitation (CPR). However ETI during CPR is a highly&#xD;
      skill-dependent procedure, then it should be attempted only highly trained physicians.&#xD;
      Because of technical difficulty in using direct laryngoscopy (DL), various types of&#xD;
      videolaryngoscopy (VL) devices using micro-camera technology have been designed to overcome&#xD;
      the problems of DL.&#xD;
&#xD;
      This study tried to compare the recovery of spontaneous circulation (ROSC) and survival&#xD;
      discharge between use of standard device (DL) and VL in a real clinical setting. In addition,&#xD;
      this study also compare the first pass success rate of ETI,speed of ETI, incidences of&#xD;
      complications, and chest compression interruptions during cardiopulmonary resuscitation&#xD;
      between both device users.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2011</start_date>
  <completion_date type="Actual">March 1, 2016</completion_date>
  <primary_completion_date type="Actual">March 1, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival with good neurologic outcome</measure>
    <time_frame>6 months after emergency department visit</time_frame>
    <description>Survived patients who were conscious and able to perform independent activities of daily life (CPC1 or CPC2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ROSC</measure>
    <time_frame>within 1 hour after emergency department visit</time_frame>
    <description>Recovery of spontaneous circulation by successful resuscitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total time to complete ETI from the beginning</measure>
    <time_frame>within 1 hour after emergency department visit</time_frame>
    <description>time from the advancement of the blade into the patient's mouth to the delivery of the first successful ventilation using the bag</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication</measure>
    <time_frame>within 1 hour after emergency department visit</time_frame>
    <description>Presence of chest compression interruption, esophageal intubation and dental injuries</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Cardiopulmonary Arrest</condition>
  <arm_group>
    <arm_group_label>DL user</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Experienced emergency physicians who primarily used the direct laryngoscopy (DL) for endotracheal intubation during cardiopulmonary resuscitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VL user</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Experienced emergency physicians who primarily used the videolaryngoscopy (VL) for endotracheal intubation during cardiopulmonary resuscitation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endotracheal Intubation</intervention_name>
    <description>Insertion of endotracheal tube into the trachea and supply oxygen using the Ambu-bagging during cardiopulmonary resuscitation</description>
    <arm_group_label>DL user</arm_group_label>
    <arm_group_label>VL user</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who suffer sudden out-of hospital cardiac arrest&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac arrests from multiple trauma&#xD;
&#xD;
          -  Cases of requesting the do-not attempt resuscitation before ETI&#xD;
&#xD;
          -  Intubated cases before arrival to emergency department&#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>Sang O Park, M.D,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Emergency Medicine, Konkuk University Medical center</affiliation>
  </overall_official>
  <reference>
    <citation>Soar J, Nolan JP, Bottiger BW, Perkins GD, Lott C, Carli P, Pellis T, Sandroni C, Skrifvars MB, Smith GB, Sunde K, Deakin CD; Adult advanced life support section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 3. Adult advanced life support. Resuscitation. 2015 Oct;95:100-47. doi: 10.1016/j.resuscitation.2015.07.016. No abstract available.</citation>
    <PMID>26477701</PMID>
  </reference>
  <reference>
    <citation>Hasegawa K, Hiraide A, Chang Y, Brown DF. Association of prehospital advanced airway management with neurologic outcome and survival in patients with out-of-hospital cardiac arrest. JAMA. 2013 Jan 16;309(3):257-66. doi: 10.1001/jama.2012.187612.</citation>
    <PMID>23321764</PMID>
  </reference>
  <reference>
    <citation>Wang HE, Simeone SJ, Weaver MD, Callaway CW. Interruptions in cardiopulmonary resuscitation from paramedic endotracheal intubation. Ann Emerg Med. 2009 Nov;54(5):645-652.e1. doi: 10.1016/j.annemergmed.2009.05.024. Epub 2009 Jul 2.</citation>
    <PMID>19573949</PMID>
  </reference>
  <reference>
    <citation>Kaplan MB, Ward DS, Berci G. A new video laryngoscope-an aid to intubation and teaching. J Clin Anesth. 2002 Dec;14(8):620-6. doi: 10.1016/s0952-8180(02)00457-9.</citation>
    <PMID>12565125</PMID>
  </reference>
  <reference>
    <citation>Rothfield KP, Russo SG. Videolaryngoscopy: should it replace direct laryngoscopy? a pro-con debate. J Clin Anesth. 2012 Nov;24(7):593-7. doi: 10.1016/j.jclinane.2012.04.005.</citation>
    <PMID>23101777</PMID>
  </reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>December 17, 2017</last_update_submitted>
  <last_update_submitted_qc>December 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</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 Resuscitation</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/NCT03256019
org study id: CPRIntuVLvsDL
nct id: NCT03256019
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a clinical study based on the analysis of video-clip data of cardiopulmonary
      resuscitation (CPR) and clinical data for out of hospital cardiac arrest patients between
      2011 and 2015. Aim of study is to compare the endotracheal intubation performance and CPR
      outcomes between videolaryngoscopy (VL) and direct laryngoscopy (DL) users.
Endotracheal intubation (ETI) has been considered to be the best method of airway management
      during cardiopulmonary resuscitation (CPR). However ETI during CPR is a highly
      skill-dependent procedure, then it should be attempted only highly trained physicians.
      Because of technical difficulty in using direct laryngoscopy (DL), various types of
      videolaryngoscopy (VL) devices using micro-camera technology have been designed to overcome
      the problems of DL.

      This study tried to compare the recovery of spontaneous circulation (ROSC) and survival
      discharge between use of standard device (DL) and VL in a real clinical setting. In addition,
      this study also compare the first pass success rate of ETI,speed of ETI, incidences of
      complications, and chest compression interruptions during cardiopulmonary resuscitation
      between both device users.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival with good neurologic outcome
time frame: 6 months after emergency department visit
description: Survived patients who were conscious and able to perform independent activities of daily life (CPC1 or CPC2)
measure: ROSC
time frame: within 1 hour after emergency department visit
description: Recovery of spontaneous circulation by successful resuscitation
measure: total time to complete ETI from the beginning
time frame: within 1 hour after emergency department visit
description: time from the advancement of the blade into the patient's mouth to the delivery of the first successful ventilation using the bag
measure: complication
time frame: within 1 hour after emergency department visit
description: Presence of chest compression interruption, esophageal intubation and dental injuries
arm group label: DL user
arm group type: Active Comparator
description: Experienced emergency physicians who primarily used the direct laryngoscopy (DL) for endotracheal intubation during cardiopulmonary resuscitation.
arm group label: VL user
arm group type: Active Comparator
description: Experienced emergency physicians who primarily used the videolaryngoscopy (VL) for endotracheal intubation during cardiopulmonary resuscitation.
intervention type: Procedure
intervention name: Endotracheal Intubation
description: Insertion of endotracheal tube into the trachea and supply oxygen using the Ambu-bagging during cardiopulmonary resuscitation
arm group label: DL user
arm group label: VL user
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sang O Park, M.D,Ph.D
role: Principal Investigator
affiliation: Department of Emergency Medicine, Konkuk University Medical center
citation: Soar J, Nolan JP, Bottiger BW, Perkins GD, Lott C, Carli P, Pellis T, Sandroni C, Skrifvars MB, Smith GB, Sunde K, Deakin CD; Adult advanced life support section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 3. Adult advanced life support. Resuscitation. 2015 Oct;95:100-47. doi: 10.1016/j.resuscitation.2015.07.016. No abstract available.
PMID: 26477701
citation: Hasegawa K, Hiraide A, Chang Y, Brown DF. Association of prehospital advanced airway management with neurologic outcome and survival in patients with out-of-hospital cardiac arrest. JAMA. 2013 Jan 16;309(3):257-66. doi: 10.1001/jama.2012.187612.
PMID: 23321764
citation: Wang HE, Simeone SJ, Weaver MD, Callaway CW. Interruptions in cardiopulmonary resuscitation from paramedic endotracheal intubation. Ann Emerg Med. 2009 Nov;54(5):645-652.e1. doi: 10.1016/j.annemergmed.2009.05.024. Epub 2009 Jul 2.
PMID: 19573949
citation: Kaplan MB, Ward DS, Berci G. A new video laryngoscope-an aid to intubation and teaching. J Clin Anesth. 2002 Dec;14(8):620-6. doi: 10.1016/s0952-8180(02)00457-9.
PMID: 12565125
citation: Rothfield KP, Russo SG. Videolaryngoscopy: should it replace direct laryngoscopy? a pro-con debate. J Clin Anesth. 2012 Nov;24(7):593-7. doi: 10.1016/j.jclinane.2012.04.005.
PMID: 23101777
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