<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/NCT02992873</url>
  </required_header>
  <id_info>
    <org_study_id>NCT2</org_study_id>
    <nct_id>NCT02992873</nct_id>
  </id_info>
  <brief_title>The Scandinavian AED and Mobile Bystander Activation Trial</brief_title>
  <acronym>SAMBA</acronym>
  <official_title>The Scandinavian AED and Mobile Bystander Activation Trial - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</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>
      Sudden cardiac death is a major health problem in the western world. In Europe alone nearly&#xD;
      300 000 patients are affected annually. The majority of victims suffering from an&#xD;
      Out-of-Hospital Cardiac Arrest (OHCA have an initial cardiac rhythm that can be treated by&#xD;
      means of defibrillation. In most emergency medical systems (EMS) time to defibrillation is&#xD;
      too long and survival averages 10 %.However, when laymen operated Automated External&#xD;
      Defibrillators (AEDs) are used within the first minutes, 7 out of 10 may survive.&#xD;
&#xD;
      The aim of &quot;The Scandinavian AED and Mobile Bystander Activation&quot; (SAMBA) trial is to&#xD;
      evaluate if a Mobile Phone Positioning system and a smartphone application will increase the&#xD;
      proportions of patients with an attached Automated External Defibrillator (AED) before&#xD;
      arrival of the Emergence Medical System (EMS). Mobile phone technology and a smartphone&#xD;
      application will be used identify and recruit nearby CPR-trained lay people and automated&#xD;
      external defibrillators (AEDs) to patients suffering out-of-hospital cardiac arrest (OHCA).&#xD;
      The system is currently running in Stockholm Sweden and in the Gothenburg region.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early defibrillation in out-of-hospital cardiac arrest is associated with high survival&#xD;
      rates. If the operator at the dispatch center suspects an out-of-hospital cardiac arrest he&#xD;
      or she will activate the mobile positioning system (MPS) wich is integrated in the operators&#xD;
      computer environment.&#xD;
&#xD;
      After activation, the system will locate all CPR-trained volunteers nearby the suspected&#xD;
      OHCA. By computer based 1:1 randomization lay volunteers will be alerted and dispatched in 50&#xD;
      % of all suspected OHCAs in where the system is triggered by the dispatchers. In the&#xD;
      intervention group, the activation of the system is supposed to result in lay volunteers to&#xD;
      be alerted and directed to fetch the nearest AED and commence early defibrillation. Dependent&#xD;
      on geographical and logistical circumstances, at a minimum one lay volunteer or more will be&#xD;
      alerted to provide bystander CPR only.&#xD;
&#xD;
      In the control group the MPS will be activated and lay responders will be dispatched to&#xD;
      suspected OHCA to perform CPR only. In both groups the ordinary EMS services are dispatched&#xD;
      in a regular fashion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">October 20, 2020</completion_date>
  <primary_completion_date type="Actual">October 20, 2020</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 (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with AED attached prior to arrival of EMS, fire or police services.</measure>
    <time_frame>12 months</time_frame>
    <description>Attached public AED before arrival of EMS or first responders (fire, police).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with bystander CPR prior to arrival of EMS, fire or police services.</measure>
    <time_frame>12 months</time_frame>
    <description>Any bystander CPR before arrival of EMS, fire or police services</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients defibrillated before arrival of EMS, fire or police services arrival.</measure>
    <time_frame>12 months</time_frame>
    <description>Use of (defibrillation) AED before EMS (ambulance fire and police) arrival.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events prehospital</measure>
    <time_frame>12 months</time_frame>
    <description>All adverse events reported at a prehospital stage will be collected and presented as minor or major events related to lay persons participating as mobile phone dispatched rescuers events related to patients. Minor events are negative safety events with the potential to harm the lay rescuer or patient such as technical malfunction or dispatcher related communication failure. Major events are negative events that actually harms the lay rescuer or OHCA patient due to system malfunction, such as unsafe scene or violation of integrity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of CRP by mobile phone dispatched lay volunteers. Both study groups combined.</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Additional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse advents in relation to SMS -alerts, AED use and lay responders</measure>
    <time_frame>12 months</time_frame>
    <description>Adverse events concerning the dispatch of lay volunteers</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of AED attachment prior to the EMS by mobile phone dispatched lay volunteers. Both study groups combined.</measure>
    <time_frame>12 months</time_frame>
    <description>Additional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">815</enrollment>
  <condition>Out-Of-Hospital Cardiac Arrest</condition>
  <condition>Cardiac Arrest, Sudden</condition>
  <arm_group>
    <arm_group_label>Layperson allocated to fetch an AED and start CPR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the intervention group mobile lifesavers will be directed to fetch the nearest AED and then attach it to the victim of OHCA. At least 1 volunteer will be directed to start CPR only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Layperson allocated to start CPR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the control group all mobile lifesavers will be directed to the patient to start CPR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Layperson allocated to start CPR and fetch nearest AED</intervention_name>
    <description>Dispatching laypersons to fetch an AED and start CPR in out-of-hospital cardiac arrest</description>
    <arm_group_label>Layperson allocated to fetch an AED and start CPR</arm_group_label>
    <other_name>Dispatch to start CPR and fetch nearest AED</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Layperson allocated to start CPR</intervention_name>
    <description>Dispatching laypersons to start CPR out-of-hospital cardiac arrest</description>
    <arm_group_label>Layperson allocated to start CPR</arm_group_label>
    <other_name>Dispatch to start CPR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All EMS-treated OHCAs within the Stockholm County, Copenhagen and VGR area and in whom&#xD;
             the mobile positioning system is activated at the emergency dispatch center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Crew witnessed OHCAs&#xD;
&#xD;
          -  Patients &lt;8 years of age&#xD;
&#xD;
          -  OHCAs due to trauma, intoxication, or suicide&#xD;
&#xD;
          -  OHCAs not treated by the EMS due to ethical reasons or obvious signs of death.&#xD;
&#xD;
          -  No OHCA cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mattias Ringh, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jacob Hollenberg, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Västra Götaland</name>
      <address>
        <city>Gothenburg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stockholm, Sweden</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Jacob Hollenberg</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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>
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02992873
org study id: NCT2
nct id: NCT02992873
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Sudden cardiac death is a major health problem in the western world. In Europe alone nearly
      300 000 patients are affected annually. The majority of victims suffering from an
      Out-of-Hospital Cardiac Arrest (OHCA have an initial cardiac rhythm that can be treated by
      means of defibrillation. In most emergency medical systems (EMS) time to defibrillation is
      too long and survival averages 10 %.However, when laymen operated Automated External
      Defibrillators (AEDs) are used within the first minutes, 7 out of 10 may survive.

      The aim of "The Scandinavian AED and Mobile Bystander Activation" (SAMBA) trial is to
      evaluate if a Mobile Phone Positioning system and a smartphone application will increase the
      proportions of patients with an attached Automated External Defibrillator (AED) before
      arrival of the Emergence Medical System (EMS). Mobile phone technology and a smartphone
      application will be used identify and recruit nearby CPR-trained lay people and automated
      external defibrillators (AEDs) to patients suffering out-of-hospital cardiac arrest (OHCA).
      The system is currently running in Stockholm Sweden and in the Gothenburg region.
Early defibrillation in out-of-hospital cardiac arrest is associated with high survival
      rates. If the operator at the dispatch center suspects an out-of-hospital cardiac arrest he
      or she will activate the mobile positioning system (MPS) wich is integrated in the operators
      computer environment.

      After activation, the system will locate all CPR-trained volunteers nearby the suspected
      OHCA. By computer based 1:1 randomization lay volunteers will be alerted and dispatched in 50
      % of all suspected OHCAs in where the system is triggered by the dispatchers. In the
      intervention group, the activation of the system is supposed to result in lay volunteers to
      be alerted and directed to fetch the nearest AED and commence early defibrillation. Dependent
      on geographical and logistical circumstances, at a minimum one lay volunteer or more will be
      alerted to provide bystander CPR only.

      In the control group the MPS will be activated and lay responders will be dispatched to
      suspected OHCA to perform CPR only. In both groups the ordinary EMS services are dispatched
      in a regular fashion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
measure: Proportion of patients with AED attached prior to arrival of EMS, fire or police services.
time frame: 12 months
description: Attached public AED before arrival of EMS or first responders (fire, police).
measure: Proportion of patients with bystander CPR prior to arrival of EMS, fire or police services.
time frame: 12 months
description: Any bystander CPR before arrival of EMS, fire or police services
measure: Proportion of patients defibrillated before arrival of EMS, fire or police services arrival.
time frame: 12 months
description: Use of (defibrillation) AED before EMS (ambulance fire and police) arrival.
measure: Adverse events prehospital
time frame: 12 months
description: All adverse events reported at a prehospital stage will be collected and presented as minor or major events related to lay persons participating as mobile phone dispatched rescuers events related to patients. Minor events are negative safety events with the potential to harm the lay rescuer or patient such as technical malfunction or dispatcher related communication failure. Major events are negative events that actually harms the lay rescuer or OHCA patient due to system malfunction, such as unsafe scene or violation of integrity.
measure: Proportion of CRP by mobile phone dispatched lay volunteers. Both study groups combined.
time frame: up to 12 months
description: Additional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)
measure: Adverse advents in relation to SMS -alerts, AED use and lay responders
time frame: 12 months
description: Adverse events concerning the dispatch of lay volunteers
measure: Proportion of AED attachment prior to the EMS by mobile phone dispatched lay volunteers. Both study groups combined.
time frame: 12 months
description: Additional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)
arm group label: Layperson allocated to fetch an AED and start CPR
arm group type: Experimental
description: In the intervention group mobile lifesavers will be directed to fetch the nearest AED and then attach it to the victim of OHCA. At least 1 volunteer will be directed to start CPR only
arm group label: Layperson allocated to start CPR
arm group type: Active Comparator
description: In the control group all mobile lifesavers will be directed to the patient to start CPR.
intervention type: Device
intervention name: Layperson allocated to start CPR and fetch nearest AED
description: Dispatching laypersons to fetch an AED and start CPR in out-of-hospital cardiac arrest
arm group label: Layperson allocated to fetch an AED and start CPR
other name: Dispatch to start CPR and fetch nearest AED
intervention type: Device
intervention name: Layperson allocated to start CPR
description: Dispatching laypersons to start CPR out-of-hospital cardiac arrest
arm group label: Layperson allocated to start CPR
other name: Dispatch to start CPR
criteria: 
gender: All
minimum age: 8 Years
maximum age: 120 Years
healthy volunteers: No
last name: Mattias Ringh, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Jacob Hollenberg, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Jacob Hollenberg
investigator title: Associate Professor
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest
mesh term: Death, Sudden, Cardiac
sharing ipd: No