<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/NCT01665755</url>
  </required_header>
  <id_info>
    <org_study_id>2011/456/C</org_study_id>
    <nct_id>NCT01665755</nct_id>
  </id_info>
  <brief_title>To Determine Optimal Time for Delivering Electrical Shocks to Cardiac Arrest Patients</brief_title>
  <official_title>A Multicenter Randomised Controlled Trial Comparing Shock Success With Synchronized Defibrillation (Compression Upstroke Versus Precompression) During Ongoing Mechanical Cardiopulmonary Resuscitation In The Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zoll Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Singapore General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, we are comparing the difference in outcomes between patients who were given&#xD;
      shocks to the heart, during the upstroke of cardiopulmonary resuscitation (CPR) and before&#xD;
      CPR is started. The study population will be all cardiac arrest patients attended by the&#xD;
      staff of the Emergency Department who fulfil the eligibility criteria. Patients will be&#xD;
      managed according to currently approved cardiac arrest protocols. Patients confirmed in&#xD;
      cardiac arrest have manual chest compressions started while mechanical CPR (whereby chest&#xD;
      compressions are delivered by an automated device) is prepared. Mechanical CPR should be&#xD;
      started as soon as possible (&lt;1 minute). If patients are eligible to be shocked, they will&#xD;
      receive shocks either during upstroke of CPR or before CPR is started.&#xD;
&#xD;
      Thus the purpose of this study is to answer the question whether are there improvement in&#xD;
      survival between when shocks are given during upstroke and before CPR is started.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study will be to compare shock success during defibrillation synchronized&#xD;
      with the upstroke of chest compression (peak upstroke), and precompression (control). This&#xD;
      will be the world's first study to characterize the phase dependency of defibrillation during&#xD;
      mechanical CPR in humans and to evaluate if optimal synchronized defibrillation can improve&#xD;
      clinical outcomes.&#xD;
&#xD;
      The null hypothesis would be that there is no difference in shock success during&#xD;
      defibrillation synchronized with the upstroke of chest compression (peak upstroke), and&#xD;
      precompression (control). We will conduct statistical comparisons for the primary and&#xD;
      secondary outcomes between the arms of the study.&#xD;
&#xD;
      The study population will be all cardiac arrest patients attended by the staff of the ED over&#xD;
      the study period who fulfill the eligibility criteria. Patients will be managed according to&#xD;
      currently approved cardiac arrest protocols. Patients confirmed in cardiac arrest with have&#xD;
      manual chest compressions started while mechanical CPR is prepared. Mechanical CPR should be&#xD;
      started as soon as possible (&lt;1 minunte). If a shockable rhythm is present (VF/VT), patients&#xD;
      will receive one of pre-randomized defibrillation protocols:&#xD;
&#xD;
        1. Synchronised defibrillation at peak-upstroke&#xD;
&#xD;
        2. Synchronised defibrillation at precompression&#xD;
&#xD;
      Definition of outcomes&#xD;
&#xD;
        -  Shock success is defined as the termination of Ventricular Fibrillation (VF) or&#xD;
           pulseless Ventricular Tachycardia (VT) and the establishment of organized rhythm within&#xD;
           60 seconds. An organized rhythm requires at least 2 QRS complexes separated by no more&#xD;
           than 5 seconds.&#xD;
&#xD;
        -  Survival to hospital discharge is defined as patient surviving the primary event and&#xD;
           discharged from the hospital alive.&#xD;
&#xD;
        -  Return of spontaneous circulation is defined as the presence of any palpable pulse,&#xD;
           which is detected by manual palpation of a major artery.&#xD;
&#xD;
        -  Survival to admission is defined as the admission to hospital without ongoing CPR or&#xD;
           other artificial circulatory support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">April 3, 2019</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>successful electrical conversion (shock success)</measure>
    <time_frame>establishment of organized rhythm within 60 seconds</time_frame>
    <description>Termination of Ventricular Fibrillation (VF) or pulseless Ventricular Tachycardia (VT) and the establishment of organized rhythm within 60 seconds. An organized rhythm requires at least 2 QRS complexes separated by no more than 5 seconds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>termination of VF regardless of the resulting rhythm</measure>
    <time_frame>at least 5 seconds after the shock</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return of spontaneous circulation (ROSC)</measure>
    <time_frame>at least 20 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival to hospital admission</measure>
    <time_frame>at least 1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival to hospital discharge</measure>
    <time_frame>at least 1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional survival outcomes assessed by the Glasgow Outcomes Score (CPC/OPC)</measure>
    <time_frame>at least 1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of Life in 5 Dimensions</measure>
    <time_frame>at least 1 day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Cardiac Event</condition>
  <condition>Sudden Cardiac Death</condition>
  <condition>Death</condition>
  <condition>Ventricular Fibrillation</condition>
  <condition>Ventricular Tachycardia</condition>
  <arm_group>
    <arm_group_label>Precompression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Control arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Upstroke Compression</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Upstroke Compression Defibrillation</intervention_name>
    <arm_group_label>Upstroke Compression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Precompression Defibrillation</intervention_name>
    <arm_group_label>Precompression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cardiac Arrest patients who received eith CPR and/or defibrillation&#xD;
&#xD;
          -  Ventricular Fibrillation or Pulseless Ventricular Tachycardia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients pronounced dead without attempting CPR according to standard operating&#xD;
             procedure and ILCOR guidelines&#xD;
&#xD;
          -  Cardiac arrest obviously caused by major trauma&#xD;
&#xD;
          -  Children below age 21&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcus Eng Hock Ong, MBBS, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Singapore General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>September 18, 2019</last_update_submitted>
  <last_update_submitted_qc>September 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</mesh_term>
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
    <mesh_term>Ventricular Fibrillation</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Death</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/NCT01665755
org study id: 2011/456/C
nct id: NCT01665755
lead sponsor: 
collaborator: 
has dmc: Yes
In this study, we are comparing the difference in outcomes between patients who were given
      shocks to the heart, during the upstroke of cardiopulmonary resuscitation (CPR) and before
      CPR is started. The study population will be all cardiac arrest patients attended by the
      staff of the Emergency Department who fulfil the eligibility criteria. Patients will be
      managed according to currently approved cardiac arrest protocols. Patients confirmed in
      cardiac arrest have manual chest compressions started while mechanical CPR (whereby chest
      compressions are delivered by an automated device) is prepared. Mechanical CPR should be
      started as soon as possible (<1 minute). If patients are eligible to be shocked, they will
      receive shocks either during upstroke of CPR or before CPR is started.

      Thus the purpose of this study is to answer the question whether are there improvement in
      survival between when shocks are given during upstroke and before CPR is started.
The purpose of this study will be to compare shock success during defibrillation synchronized
      with the upstroke of chest compression (peak upstroke), and precompression (control). This
      will be the world's first study to characterize the phase dependency of defibrillation during
      mechanical CPR in humans and to evaluate if optimal synchronized defibrillation can improve
      clinical outcomes.

      The null hypothesis would be that there is no difference in shock success during
      defibrillation synchronized with the upstroke of chest compression (peak upstroke), and
      precompression (control). We will conduct statistical comparisons for the primary and
      secondary outcomes between the arms of the study.

      The study population will be all cardiac arrest patients attended by the staff of the ED over
      the study period who fulfill the eligibility criteria. Patients will be managed according to
      currently approved cardiac arrest protocols. Patients confirmed in cardiac arrest with have
      manual chest compressions started while mechanical CPR is prepared. Mechanical CPR should be
      started as soon as possible (<1 minunte). If a shockable rhythm is present (VF/VT), patients
      will receive one of pre-randomized defibrillation protocols:

        1. Synchronised defibrillation at peak-upstroke

        2. Synchronised defibrillation at precompression

      Definition of outcomes

        -  Shock success is defined as the termination of Ventricular Fibrillation (VF) or
           pulseless Ventricular Tachycardia (VT) and the establishment of organized rhythm within
           60 seconds. An organized rhythm requires at least 2 QRS complexes separated by no more
           than 5 seconds.

        -  Survival to hospital discharge is defined as patient surviving the primary event and
           discharged from the hospital alive.

        -  Return of spontaneous circulation is defined as the presence of any palpable pulse,
           which is detected by manual palpation of a major artery.

        -  Survival to admission is defined as the admission to hospital without ongoing CPR or
           other artificial circulatory support.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: successful electrical conversion (shock success)
time frame: establishment of organized rhythm within 60 seconds
description: Termination of Ventricular Fibrillation (VF) or pulseless Ventricular Tachycardia (VT) and the establishment of organized rhythm within 60 seconds. An organized rhythm requires at least 2 QRS complexes separated by no more than 5 seconds.
measure: termination of VF regardless of the resulting rhythm
time frame: at least 5 seconds after the shock
measure: Return of spontaneous circulation (ROSC)
time frame: at least 20 minutes
measure: Survival to hospital admission
time frame: at least 1 day
measure: Survival to hospital discharge
time frame: at least 1 day
measure: Functional survival outcomes assessed by the Glasgow Outcomes Score (CPC/OPC)
time frame: at least 1 day
measure: European Quality of Life in 5 Dimensions
time frame: at least 1 day
arm group label: Precompression
arm group type: Experimental
description: Control arm
arm group label: Upstroke Compression
arm group type: Active Comparator
description: Intervention arm
intervention type: Device
intervention name: Upstroke Compression Defibrillation
arm group label: Upstroke Compression
intervention type: Device
intervention name: Precompression Defibrillation
arm group label: Precompression
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Marcus Eng Hock Ong, MBBS, FRCS
role: Principal Investigator
affiliation: Singapore General Hospital
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
mesh term: Death, Sudden, Cardiac
mesh term: Ventricular Fibrillation
mesh term: Cardiovascular Diseases
mesh term: Death