<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/NCT02184468</url>
  </required_header>
  <id_info>
    <org_study_id>SAMS 242-11</org_study_id>
    <nct_id>NCT02184468</nct_id>
  </id_info>
  <brief_title>Survival Study After Out-of-hospital Cardiac Arrest</brief_title>
  <acronym>SAMS</acronym>
  <official_title>Dual Dispatch of EMS, Fire Fighters and/or Police in Out-of-hospital Cardiac Arrest Implemented in Nine Counties in Sweden - Can More Lives be Saved by Using This Method?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Laerdal Foundation for Acute Medicine in Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swedish Heart Lung Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health and Social Affairs, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swedish Association of Local Authorities and Regions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if dual dispatch of ambulance, fire fighters and/or&#xD;
      police in out-of-hospital cardiac arrest (OHCA), can reduce the time to cardiopulmonary&#xD;
      resuscitation (CPR) and defibrillation, thus increasing survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis If simultaneous dispatch of ambulance (EMS), firefighters and/or police is being&#xD;
      initiated when an OHCA occurs, then the two latter units will be first at scene, before the&#xD;
      ambulance crew, in ≥30% of the cases. We anticipate therefore that overall 30-days survival&#xD;
      will increase on a national level from 9% to 12%.&#xD;
&#xD;
      Method During the period 110901 to 141231 all OHCA cases will be analyzed were the emergency&#xD;
      medical communication centre (EMCC) has dispatched ambulance, firefighters and/or the police.&#xD;
      Participating in the Saving More Lives in Sweden (SAMS) project are the following counties:&#xD;
      Stockholm, Sodermanland, Jonkoping, Vastra Gotaland (VG Region), Halland, Dalarna, Jamtland,&#xD;
      Kalmar and Uppsala. Data is collected by the units being dispatched and thereafter sent on&#xD;
      line to a database managed by Registercentrum in Gothenburg (http://www.registercentrum.se/),&#xD;
      administrators of the Swedish Cardiac Arrest Register.&#xD;
&#xD;
      Parameters obtained are:&#xD;
&#xD;
        -  Time for dispatch of fire fighters and/or police (recorded digitally).&#xD;
&#xD;
        -  Time for arrival to the patient.&#xD;
&#xD;
        -  Verification if cardiac arrest or not.&#xD;
&#xD;
        -  CPR performed by fire fighters or police before arrival of EMS.&#xD;
&#xD;
        -  Automated External Defibrillator (AED) connected to the patient.&#xD;
&#xD;
        -  If yes, was the first recorded rhythm shockable, i.e. ventricular fibrillation (VF) or&#xD;
           pulseless ventricular tachycardia (VT).&#xD;
&#xD;
        -  Time to defibrillation.&#xD;
&#xD;
      Survival data during from the Swedish Cardiac Arrest Register (SCAR) will be obtained during&#xD;
      the same time period from nine comparable Swedish regions not participating in the SAMS&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>30-days after out-of-hospital cardiac arrest (OHCA)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time for dispatching of fire fighters and/or police</measure>
    <time_frame>Up to 1 y after ending recruitement</time_frame>
    <description>Data are obtained digitally from the dispatch center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for arrival to the patient</measure>
    <time_frame>Up to 1 y after ending recruitement</time_frame>
    <description>Data are collected both digitally from the dispatch center and from protocols sent in on line by first responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for attaching the defibrillator to the patient</measure>
    <time_frame>Up to 1 y after ending recruitement</time_frame>
    <description>Data are collected from protocols sent in on line by first responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first defibrillation</measure>
    <time_frame>Up to 1 y after ending recruitement</time_frame>
    <description>Data collected from the protocol sent in on line by first responders.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Out-of-Hospital Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Dual dispatch</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Simultaneously dispatching of EMS, firefighters and/or police in OHCA</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simultaneously dispatch of firefighters and/or police in case of OHCA</intervention_name>
    <description>In case of OHCA, firefighters and/or police trained in CPR and equipped with AEDs will be dispatched in parallel with EMS in nine counties in Sweden.</description>
    <arm_group_label>Dual dispatch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All cases where the dispatcher suspects cardiac arrest, i.e. unconscious person with&#xD;
             abnormal or no breathing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children &lt; 8 y&#xD;
&#xD;
          -  Obviously deceased persons according to regulations in EMS protocols&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leif Svensson, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Resuscitation Science, Karolinska Institutet, Stockholm, Sweden</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Leif Svensson</last_name>
    <phone>+4686161000</phone>
    <email>leif.svensson@ki.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Johan Herlitz</last_name>
    <phone>+46334354000</phone>
    <email>johan.herlitz@gu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Center for Resuscitation Science, Sodersjukhuset</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-11883</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leif Svensson, MD, PhD</last_name>
      <phone>+4686161000</phone>
      <email>leif.svensson@ki.se</email>
    </contact>
    <contact_backup>
      <last_name>Johan Herlitz, MD, PhD</last_name>
      <phone>+46334354000</phone>
      <email>johan.herlitz@gu.se</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 8, 2014</last_update_submitted>
  <last_update_submitted_qc>July 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Leif Svensson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Cardiac Arrest</keyword>
  <keyword>Out-of-Hospital Cardiac Arrest</keyword>
  <keyword>Firefighters</keyword>
  <keyword>Police</keyword>
  <keyword>Defibrillators</keyword>
  <keyword>Survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Out-of-Hospital Cardiac 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/NCT02184468
org study id: SAMS 242-11
nct id: NCT02184468
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if dual dispatch of ambulance, fire fighters and/or
      police in out-of-hospital cardiac arrest (OHCA), can reduce the time to cardiopulmonary
      resuscitation (CPR) and defibrillation, thus increasing survival.
Hypothesis If simultaneous dispatch of ambulance (EMS), firefighters and/or police is being
      initiated when an OHCA occurs, then the two latter units will be first at scene, before the
      ambulance crew, in ≥30% of the cases. We anticipate therefore that overall 30-days survival
      will increase on a national level from 9% to 12%.

      Method During the period 110901 to 141231 all OHCA cases will be analyzed were the emergency
      medical communication centre (EMCC) has dispatched ambulance, firefighters and/or the police.
      Participating in the Saving More Lives in Sweden (SAMS) project are the following counties:
      Stockholm, Sodermanland, Jonkoping, Vastra Gotaland (VG Region), Halland, Dalarna, Jamtland,
      Kalmar and Uppsala. Data is collected by the units being dispatched and thereafter sent on
      line to a database managed by Registercentrum in Gothenburg (http://www.registercentrum.se/),
      administrators of the Swedish Cardiac Arrest Register.

      Parameters obtained are:

        -  Time for dispatch of fire fighters and/or police (recorded digitally).

        -  Time for arrival to the patient.

        -  Verification if cardiac arrest or not.

        -  CPR performed by fire fighters or police before arrival of EMS.

        -  Automated External Defibrillator (AED) connected to the patient.

        -  If yes, was the first recorded rhythm shockable, i.e. ventricular fibrillation (VF) or
           pulseless ventricular tachycardia (VT).

        -  Time to defibrillation.

      Survival data during from the Swedish Cardiac Arrest Register (SCAR) will be obtained during
      the same time period from nine comparable Swedish regions not participating in the SAMS
      study.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Survival
time frame: 30-days after out-of-hospital cardiac arrest (OHCA)
measure: Time for dispatching of fire fighters and/or police
time frame: Up to 1 y after ending recruitement
description: Data are obtained digitally from the dispatch center.
measure: Time for arrival to the patient
time frame: Up to 1 y after ending recruitement
description: Data are collected both digitally from the dispatch center and from protocols sent in on line by first responders.
measure: Time for attaching the defibrillator to the patient
time frame: Up to 1 y after ending recruitement
description: Data are collected from protocols sent in on line by first responders.
measure: Time to first defibrillation
time frame: Up to 1 y after ending recruitement
description: Data collected from the protocol sent in on line by first responders.
arm group label: Dual dispatch
arm group type: Other
description: Simultaneously dispatching of EMS, firefighters and/or police in OHCA
intervention type: Other
intervention name: Simultaneously dispatch of firefighters and/or police in case of OHCA
description: In case of OHCA, firefighters and/or police trained in CPR and equipped with AEDs will be dispatched in parallel with EMS in nine counties in Sweden.
arm group label: Dual dispatch
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
last name: Leif Svensson, MD, PhD
role: Principal Investigator
affiliation: Center for Resuscitation Science, Karolinska Institutet, Stockholm, Sweden
last name: Leif Svensson
phone: +4686161000
email: leif.svensson@ki.se
last name: Johan Herlitz
phone: +46334354000
email: johan.herlitz@gu.se
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Leif Svensson
investigator title: Professor
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest