<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/NCT03249948</url>
  </required_header>
  <id_info>
    <org_study_id>DOSE-VF-PILOT</org_study_id>
    <nct_id>NCT03249948</nct_id>
  </id_info>
  <brief_title>DOuble SEquential External Defibrillation for Refractory VF Pilot Study</brief_title>
  <acronym>DOSE-VF</acronym>
  <official_title>DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation - DOSE VF Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peel Regional Paramedic Service</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Toronto Paramedic Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Halton Region Paramedic Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>County of Simcoe Paramedic Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</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>
      Despite significant advances in resuscitation efforts, there are some patients who remain in&#xD;
      refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. Double&#xD;
      sequential external defibrillation (DSED) and vector change defibrillation have been proposed&#xD;
      as a viable option for patients in refractory VF. This pilot cluster randomized trial will&#xD;
      compare (1) continued resuscitation using standard defibrillation; (2) resuscitation&#xD;
      involving DSED; or (3) resuscitation involving vector change defibrillation, in patients&#xD;
      presenting with refractory VF during out-of-hospital cardiac arrest. The results of this&#xD;
      pilot study will provide critical data for planning a larger, adequately powered multi-site&#xD;
      randomized controlled trial to clinically evaluate DSED and vector change defibrillation&#xD;
      compared to standard therapy for patients in refractory VF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Double sequential external defibrillation (DSED) and vector change defibrillation have been&#xD;
      proposed as viable options for patients in refractory ventricular fibrillation (VF) during&#xD;
      out-of-hospital cardiac arrest. However, currently there is insufficient evidence to support&#xD;
      a widespread implementation of this therapy. As such, a well-designed randomized controlled&#xD;
      trial (RCT) employing a standardized approach to alternative defibrillation strategies early&#xD;
      in the treatment of refractory VF is required to determine whether these treatments may&#xD;
      impact clinical outcomes. This pilot cluster randomized trial will be conducted in the&#xD;
      regions of Peel, Halton, Simcoe, and the city of Toronto, Ontario, Canada over a one year&#xD;
      period of time. All adult (≥ 18 years) patients presenting in refractory VF (defined as&#xD;
      patients presenting in VF and remaining in VF after three consecutive standard defibrillation&#xD;
      attempts each separated by 2 minutes of CPR) during out-of-hospital cardiac arrest of&#xD;
      presumed cardiac etiology will be assigned to be treated by one of three strategies: (1)&#xD;
      continued resuscitation using standard defibrillation; (2) resuscitation involving DSED (two&#xD;
      defibrillators, one using anterior-posterior pad placement and the second using anterior-&#xD;
      anterior pad placement delivering two rapid sequential shocks for all subsequent&#xD;
      defibrillation attempts, ± antiarrythmic use and epinephrine as per current provincial&#xD;
      standard); or (3) resuscitation involving vector change (change of defibrillation pads from&#xD;
      anterior-anterior to an anterior-posterior pad position) defibrillation. The cluster units&#xD;
      will be defined by emergency medical service (EMS) agency and each cluster will crossover at&#xD;
      three times during the trial so that each agency will spend 4 months in each arm of the&#xD;
      study. Outcomes of interest will include return of spontaneous circulation (ROSC),&#xD;
      termination of VF after the first interventional shock, termination of VF inclusive of all&#xD;
      interventional shocks, and number of defibrillation attempts to obtain ROSC. The primary&#xD;
      objectives of the pilot study are to determine the feasibility and required sample size of a&#xD;
      full-scale RCT in this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2018</start_date>
  <completion_date type="Actual">March 12, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>This is a cluster randomized study, with cluster units defined by EMS agency. Each cluster will crossover at three times during the one year trial so that each agency will spend 4 months in each arm of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Return of spontaneous circulation (ROSC)</measure>
    <time_frame>1 day</time_frame>
    <description>Binary outcome of whether or not patient returned to spontaneous circulation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of double sequential external defibrillation</measure>
    <time_frame>Day 1</time_frame>
    <description>80% or greater of patients receiving proper randomization and 80% or greater receiving an intervention shock prior to shock 6</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VF termination after first interventional shock</measure>
    <time_frame>1 day</time_frame>
    <description>Cessation of the VF waveform on defibrillator monitor at first rhythm analysis post interventional or standard shock. The interpretation will occur after three standard shocks have failed to terminate VF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VF termination inclusive of all interventional shocks</measure>
    <time_frame>1 day</time_frame>
    <description>Cessation of the VF waveform on defibrillator monitor at any rhythm analysis post interventional or standard shock. The interpretation will occur after three standard shocks have failed to terminate VF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of defibrillation attempts to obtain ROSC</measure>
    <time_frame>1 day</time_frame>
    <description>Total number of shocks required to achieve the first ROSC during resuscitation, inclusive of the first three standard shocks.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">173</enrollment>
  <condition>Ventricular Fibrillation</condition>
  <arm_group>
    <arm_group_label>Standard defibrillation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All defibrillation attempts will occur using the standard defibrillation method, i.e. defibrillation pads will be placed in the anterior-anterior configuration. The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vector change defibrillation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The first three shocks will occur with defibrillation pads placed in the anterior-anterior position. All further shocks will occur with the pads placed in the anterior-posterior position. The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Double-sequential defibrillation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The first three shocks will occur with defibrillation pads placed in the anterior-anterior position. For all further shocks, a second set of defibrillation pads (via a second on scene EMS or fire defibrillator) will be applied in the anterior-posterior position, and defibrillation will be carried out by sequential defibrillation shocks provided by the two defibrillators (i.e. with a short delay between the two defibrillators). The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vector change defibrillation</intervention_name>
    <description>Defibrillation using pad placement in anterior-posterior position.</description>
    <arm_group_label>Vector change defibrillation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Double-sequential defibrillation</intervention_name>
    <description>Defibrillation using two defibrillators, one with pad placement in anterior-posterior position, and the other with pad placement in anterior-anterior position, delivering two rapid sequential shocks.</description>
    <arm_group_label>Double-sequential defibrillation</arm_group_label>
    <other_name>Double sequential external defibrillation</other_name>
    <other_name>DSED</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age, non-traumatic cardiac arrest of presumed cardiac etiology,&#xD;
             presenting rhythm to EMS of ventricular fibrillation; no ROSC or non VF rhythm after&#xD;
             three consecutive EMS shocks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Traumatic cardiac arrest, patients with pre-existing do not resuscitate orders,&#xD;
             presumed pregnancy, patients in recurrent ventricular fibrillation (defined as those&#xD;
             with a secondary presentation of VF (not the presenting rhythm) or those presenting in&#xD;
             VF but did not receive three consecutive defibrillation attempts).&#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>Sheldon Cheskes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Centre for Prehospital Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peel Regional Paramedic Service</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Halton Region Paramedic Services</name>
      <address>
        <city>Oakville</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>County of Simcoe Paramedic Services</name>
      <address>
        <city>Simcoe</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Paramedic Services</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>March 17, 2020</last_update_submitted>
  <last_update_submitted_qc>March 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</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>Ventricular Fibrillation</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/NCT03249948
org study id: DOSE-VF-PILOT
nct id: NCT03249948
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Despite significant advances in resuscitation efforts, there are some patients who remain in
      refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. Double
      sequential external defibrillation (DSED) and vector change defibrillation have been proposed
      as a viable option for patients in refractory VF. This pilot cluster randomized trial will
      compare (1) continued resuscitation using standard defibrillation; (2) resuscitation
      involving DSED; or (3) resuscitation involving vector change defibrillation, in patients
      presenting with refractory VF during out-of-hospital cardiac arrest. The results of this
      pilot study will provide critical data for planning a larger, adequately powered multi-site
      randomized controlled trial to clinically evaluate DSED and vector change defibrillation
      compared to standard therapy for patients in refractory VF.
Double sequential external defibrillation (DSED) and vector change defibrillation have been
      proposed as viable options for patients in refractory ventricular fibrillation (VF) during
      out-of-hospital cardiac arrest. However, currently there is insufficient evidence to support
      a widespread implementation of this therapy. As such, a well-designed randomized controlled
      trial (RCT) employing a standardized approach to alternative defibrillation strategies early
      in the treatment of refractory VF is required to determine whether these treatments may
      impact clinical outcomes. This pilot cluster randomized trial will be conducted in the
      regions of Peel, Halton, Simcoe, and the city of Toronto, Ontario, Canada over a one year
      period of time. All adult (≥ 18 years) patients presenting in refractory VF (defined as
      patients presenting in VF and remaining in VF after three consecutive standard defibrillation
      attempts each separated by 2 minutes of CPR) during out-of-hospital cardiac arrest of
      presumed cardiac etiology will be assigned to be treated by one of three strategies: (1)
      continued resuscitation using standard defibrillation; (2) resuscitation involving DSED (two
      defibrillators, one using anterior-posterior pad placement and the second using anterior-
      anterior pad placement delivering two rapid sequential shocks for all subsequent
      defibrillation attempts, ± antiarrythmic use and epinephrine as per current provincial
      standard); or (3) resuscitation involving vector change (change of defibrillation pads from
      anterior-anterior to an anterior-posterior pad position) defibrillation. The cluster units
      will be defined by emergency medical service (EMS) agency and each cluster will crossover at
      three times during the trial so that each agency will spend 4 months in each arm of the
      study. Outcomes of interest will include return of spontaneous circulation (ROSC),
      termination of VF after the first interventional shock, termination of VF inclusive of all
      interventional shocks, and number of defibrillation attempts to obtain ROSC. The primary
      objectives of the pilot study are to determine the feasibility and required sample size of a
      full-scale RCT in this population.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a cluster randomized study, with cluster units defined by EMS agency. Each cluster will crossover at three times during the one year trial so that each agency will spend 4 months in each arm of the study.
primary purpose: Treatment
masking: None (Open Label)
measure: Return of spontaneous circulation (ROSC)
time frame: 1 day
description: Binary outcome of whether or not patient returned to spontaneous circulation
measure: Feasibility of double sequential external defibrillation
time frame: Day 1
description: 80% or greater of patients receiving proper randomization and 80% or greater receiving an intervention shock prior to shock 6
measure: VF termination after first interventional shock
time frame: 1 day
description: Cessation of the VF waveform on defibrillator monitor at first rhythm analysis post interventional or standard shock. The interpretation will occur after three standard shocks have failed to terminate VF.
measure: VF termination inclusive of all interventional shocks
time frame: 1 day
description: Cessation of the VF waveform on defibrillator monitor at any rhythm analysis post interventional or standard shock. The interpretation will occur after three standard shocks have failed to terminate VF.
measure: Number of defibrillation attempts to obtain ROSC
time frame: 1 day
description: Total number of shocks required to achieve the first ROSC during resuscitation, inclusive of the first three standard shocks.
arm group label: Standard defibrillation
arm group type: No Intervention
description: All defibrillation attempts will occur using the standard defibrillation method, i.e. defibrillation pads will be placed in the anterior-anterior configuration. The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.
arm group label: Vector change defibrillation
arm group type: Other
description: The first three shocks will occur with defibrillation pads placed in the anterior-anterior position. All further shocks will occur with the pads placed in the anterior-posterior position. The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.
arm group label: Double-sequential defibrillation
arm group type: Other
description: The first three shocks will occur with defibrillation pads placed in the anterior-anterior position. For all further shocks, a second set of defibrillation pads (via a second on scene EMS or fire defibrillator) will be applied in the anterior-posterior position, and defibrillation will be carried out by sequential defibrillation shocks provided by the two defibrillators (i.e. with a short delay between the two defibrillators). The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.
intervention type: Procedure
intervention name: Vector change defibrillation
description: Defibrillation using pad placement in anterior-posterior position.
arm group label: Vector change defibrillation
intervention type: Procedure
intervention name: Double-sequential defibrillation
description: Defibrillation using two defibrillators, one with pad placement in anterior-posterior position, and the other with pad placement in anterior-anterior position, delivering two rapid sequential shocks.
arm group label: Double-sequential defibrillation
other name: Double sequential external defibrillation
other name: DSED
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sheldon Cheskes, MD
role: Principal Investigator
affiliation: Sunnybrook Centre for Prehospital Medicine
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Ventricular Fibrillation