<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/NCT03252886</url>
  </required_header>
  <id_info>
    <org_study_id>TRAUMACPRintu</org_study_id>
    <nct_id>NCT03252886</nct_id>
  </id_info>
  <brief_title>Videolaryngoscopy During CPR for Trauma Patients</brief_title>
  <official_title>The Efficacy of Videolaryngoscopy During Cardiac-pulmonary Resuscitation (CPR) for Trauma Patients With Suspect Neck Injuries</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 collected video-clip data of cardiopulmonary resuscitation&#xD;
      for patients with suspected neck injury in multiple trauma between 2011 and 2015. The study&#xD;
      aimed to compare all possible factors relating to ETI performance during CPR for truma&#xD;
      patients between experienced video-laryngoscopy and direct- laryngoscopy users.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endotracheal intubation (ETI) is considered to be the best method of airway management during&#xD;
      cardiopulmonary resuscitation (CPR). However ETI during CPR is a highly skill-dependent&#xD;
      procedure, then it should be attempted only highly trained physicians. Especially, cervical&#xD;
      immobilization by neck collar in truamatic patients is a great obstacle to successful ETI&#xD;
      during CPR.&#xD;
&#xD;
      Because of technical difficulty in using direct laryngoscopy (DL), various types of&#xD;
      videolaryngoscopy (VL) devices have been developed to overcome the problems of DL. VL may be&#xD;
      more useful to perform ETI during CPR for trauma patients with cervical immobilization.&#xD;
&#xD;
      This study tried to compare the success rate of endotracheal intubation (ETI), speed of ETI,&#xD;
      incidence of complications, and chest compression interruptions during cardiopulmonary&#xD;
      resuscitation for trauma patients with suspected neck injury between intubators using the DL&#xD;
      and the VL in a real clinical setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2011</start_date>
  <completion_date type="Actual">March 1, 2015</completion_date>
  <primary_completion_date type="Actual">March 1, 2015</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>First attempt successful ETI</measure>
    <time_frame>within 1 hour after emergency department visit</time_frame>
    <description>Successfully insertion of endotracheal tube into trachea at first attempt</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the time to complete ETI from the beginning</measure>
    <time_frame>within 1 hour after emergency department visit</time_frame>
    <description>the 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>Occurance of 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">30</enrollment>
  <condition>Cardiopulmonary Arrest</condition>
  <condition>Neck Injury Multiple</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 use the direct laryngoscopy (DL) for endotracheal intubation during cardio-pulmonary 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 use the videolaryngoscopy (VL) for endotracheal intubation during cardio-pulmonary 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;
          -  Multiple trauma patients with suspected neck injuries&#xD;
&#xD;
          -  Arrest Patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Case of requesting the do-not attempt resuscitation before ETI&#xD;
&#xD;
          -  already intubated case before arrival to hospital&#xD;
&#xD;
          -  Cardiac arrest from non-traumatic causes&#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>School of Medicine, Konkuk University</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>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>December 16, 2017</last_update_submitted>
  <last_update_submitted_qc>December 16, 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>
  <keyword>neck injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Neck Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT03252886
org study id: TRAUMACPRintu
nct id: NCT03252886
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a clinical study based on collected video-clip data of cardiopulmonary resuscitation
      for patients with suspected neck injury in multiple trauma between 2011 and 2015. The study
      aimed to compare all possible factors relating to ETI performance during CPR for truma
      patients between experienced video-laryngoscopy and direct- laryngoscopy users.
Endotracheal intubation (ETI) is 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. Especially, cervical
      immobilization by neck collar in truamatic patients is a great obstacle to successful ETI
      during CPR.

      Because of technical difficulty in using direct laryngoscopy (DL), various types of
      videolaryngoscopy (VL) devices have been developed to overcome the problems of DL. VL may be
      more useful to perform ETI during CPR for trauma patients with cervical immobilization.

      This study tried to compare the success rate of endotracheal intubation (ETI), speed of ETI,
      incidence of complications, and chest compression interruptions during cardiopulmonary
      resuscitation for trauma patients with suspected neck injury between intubators using the DL
      and the VL in a real clinical setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: First attempt successful ETI
time frame: within 1 hour after emergency department visit
description: Successfully insertion of endotracheal tube into trachea at first attempt
measure: the time to complete ETI from the beginning
time frame: within 1 hour after emergency department visit
description: the time from the advancement of the blade into the patient's mouth to the delivery of the first successful ventilation using the bag
measure: Occurance of 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 use the direct laryngoscopy (DL) for endotracheal intubation during cardio-pulmonary resuscitation.
arm group label: VL user
arm group type: Active Comparator
description: Experienced emergency physicians who primarily use the videolaryngoscopy (VL) for endotracheal intubation during cardio-pulmonary 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: School of Medicine, Konkuk University
facility: 
country: Korea, Republic of
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
mesh term: Neck Injuries