<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/NCT02967952</url>
  </required_header>
  <id_info>
    <org_study_id>201606047RINA</org_study_id>
    <nct_id>NCT02967952</nct_id>
  </id_info>
  <brief_title>A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA</brief_title>
  <acronym>SAVE</acronym>
  <official_title>A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA (SAVE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this 3-year successive research plan, investigators will conduct a prehospital randomized&#xD;
      controlled trial to address the following question: In adult patients with non-traumatic&#xD;
      cause of out-of-hospital cardiac arrest resuscitated by emergency medical technician&#xD;
      (paramedic level) in the prehospital setting, will receiving endotracheal tube intubation&#xD;
      cause a better chance of sustained recovery of spontaneous circulation and other survival&#xD;
      outcomes like neurologically favorable status, comparing to those who receiving supraglottic&#xD;
      airway device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>survival to admission</measure>
    <time_frame>One month after event</time_frame>
    <description>Measurement of outcome by standard Utstein OHCA registry system in Taipei City</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>any ROSC</measure>
    <time_frame>One month after event</time_frame>
    <description>Measurement of outcome by standard Utstein OHCA registry system in Taipei City</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>survival to discharge</measure>
    <time_frame>One month after event</time_frame>
    <description>Measurement of outcome by standard Utstein OHCA registry system in Taipei City</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>favorable neurologic outcome</measure>
    <time_frame>One month after event</time_frame>
    <description>Favorable neurologic outcome was defined by CPC (cerebral performance category) 1 and 2.&#xD;
Measurement of outcome by standard Utstein OHCA registry system in Taipei City</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The rate of survival to discharge of OHCAs resuscitated by non-paramedic (airway device: all SGA)</measure>
    <time_frame>One month after event</time_frame>
    <description>Measurement of outcome by standard Utstein OHCA registry system in Taipei City</description>
  </other_outcome>
  <other_outcome>
    <measure>The interaction between age and airway management</measure>
    <time_frame>One month after event</time_frame>
    <description>Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City</description>
  </other_outcome>
  <other_outcome>
    <measure>The interaction between bystander CPR and airway management</measure>
    <time_frame>One month after event</time_frame>
    <description>Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City</description>
  </other_outcome>
  <other_outcome>
    <measure>The interaction between shockable rhythms and airway management</measure>
    <time_frame>One month after event</time_frame>
    <description>Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">852</enrollment>
  <condition>Prehospital Airway Management in Patients With Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>supraglottic airway (SGA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adult patients with non-trauma causes of OHCA who are resuscitated by emergency medical technician paramedic (EMTP) in the prehospital setting and received airway management of supraglottic airway (SGA).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>endotracheal intubation (ETI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adult patients with non-trauma causes of OHCA who are resuscitated by emergency medical technician paramedic (EMTP) in the prehospital setting and received airway management of endotracheal intubation (ETI).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>supraglottic airway (SGA) V.S. endotracheal intubation (ETI)</intervention_name>
    <description>already being described above</description>
    <arm_group_label>endotracheal intubation (ETI)</arm_group_label>
    <arm_group_label>supraglottic airway (SGA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  out-of-hospital cardiac arrest; OHCA&#xD;
&#xD;
          -  age ≥ 20 years old&#xD;
&#xD;
          -  non-traumatic cause&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  signs of obvious death, eg. decapitation or rigor mortis&#xD;
&#xD;
          -  theoretically not suitable for ETI, eg. facial deformity or third-trimester pregnancy&#xD;
&#xD;
          -  theoretically not suitable for SGA, eg. foreign-body airway obstruction&#xD;
&#xD;
          -  with &quot;do not attempt resuscitation&quot; order&#xD;
&#xD;
          -  the occurrence of OHCA during ambulance transport&#xD;
&#xD;
          -  ROSC in the field with clear consciousness and spontaneous adequate ventilation&#xD;
&#xD;
          -  advanced airway being established before the arrival of paramedics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen-Chu Chiang, MD, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Dept, National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wen-Chu Chiang, MD, PhD.</last_name>
    <phone>+886-2-23123456</phone>
    <phone_ext>62831</phone_ext>
    <email>drchiang.tw@gmail.com</email>
  </overall_contact>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 15, 2016</last_update_submitted>
  <last_update_submitted_qc>November 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>out-of-hospital cardiac arrest (OHCA)</keyword>
  <keyword>supraglottic airway (SGA)</keyword>
  <keyword>endotracheal intubation (ETI)</keyword>
  <keyword>emergency medical system (EMS)</keyword>
  <keyword>Supraglottic Airway Versus Endotracheal tube (SAVE)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</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/NCT02967952
org study id: 201606047RINA
nct id: NCT02967952
lead sponsor: 
has dmc: Yes
In this 3-year successive research plan, investigators will conduct a prehospital randomized
      controlled trial to address the following question: In adult patients with non-traumatic
      cause of out-of-hospital cardiac arrest resuscitated by emergency medical technician
      (paramedic level) in the prehospital setting, will receiving endotracheal tube intubation
      cause a better chance of sustained recovery of spontaneous circulation and other survival
      outcomes like neurologically favorable status, comparing to those who receiving supraglottic
      airway device.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: survival to admission
time frame: One month after event
description: Measurement of outcome by standard Utstein OHCA registry system in Taipei City
measure: any ROSC
time frame: One month after event
description: Measurement of outcome by standard Utstein OHCA registry system in Taipei City
measure: survival to discharge
time frame: One month after event
description: Measurement of outcome by standard Utstein OHCA registry system in Taipei City
measure: favorable neurologic outcome
time frame: One month after event
description: Favorable neurologic outcome was defined by CPC (cerebral performance category) 1 and 2.
Measurement of outcome by standard Utstein OHCA registry system in Taipei City
measure: The rate of survival to discharge of OHCAs resuscitated by non-paramedic (airway device: all SGA)
time frame: One month after event
description: Measurement of outcome by standard Utstein OHCA registry system in Taipei City
measure: The interaction between age and airway management
time frame: One month after event
description: Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City
measure: The interaction between bystander CPR and airway management
time frame: One month after event
description: Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City
measure: The interaction between shockable rhythms and airway management
time frame: One month after event
description: Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City
arm group label: supraglottic airway (SGA)
arm group type: Active Comparator
description: Adult patients with non-trauma causes of OHCA who are resuscitated by emergency medical technician paramedic (EMTP) in the prehospital setting and received airway management of supraglottic airway (SGA).
arm group label: endotracheal intubation (ETI)
arm group type: Active Comparator
description: Adult patients with non-trauma causes of OHCA who are resuscitated by emergency medical technician paramedic (EMTP) in the prehospital setting and received airway management of endotracheal intubation (ETI).
intervention type: Device
intervention name: supraglottic airway (SGA) V.S. endotracheal intubation (ETI)
description: already being described above
arm group label: endotracheal intubation (ETI)
arm group label: supraglottic airway (SGA)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Wen-Chu Chiang, MD, PhD.
role: Principal Investigator
affiliation: Emergency Dept, National Taiwan University Hospital
last name: Wen-Chu Chiang, MD, PhD.
phone: +886-2-23123456
phone ext: 62831
email: drchiang.tw@gmail.com
responsible party type: Sponsor
mesh term: Heart Arrest