<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/NCT04485390</url>
  </required_header>
  <id_info>
    <org_study_id>UKC-MB-KME-24/20</org_study_id>
    <nct_id>NCT04485390</nct_id>
  </id_info>
  <brief_title>Impact of the Organization of the First Responders in the Remote Areas on Cardiac Arrest Victim Survival</brief_title>
  <official_title>Impact of the Organization of the First Responders in the Remote Areas on Cardiac Arrest Victim Survival: an Utstein Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Centre Maribor</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Centre Maribor</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Emergency medical services (EMS) provide emergency care not only in the urban but also in the&#xD;
      remote areas which could be up to 40 minutes from the EMS station. Thus, a cardiac arrest&#xD;
      victim in those remote areas has a low likelihood to survive the cardiopulmonary&#xD;
      resuscitation. Therefore, we have organized first responders (who are mostly volunteer&#xD;
      fire-fighters) in the remote areas and taught them how to perform basic life support (BLS)&#xD;
      with use of an automated external defibrillator (AED). In the case of a cardiac arrest the&#xD;
      medical dispatcher activates simultaneously the EMS and the first responders, who perform the&#xD;
      BLS with the use of an AED before the arrival of EMS.&#xD;
&#xD;
      The aim of the study is to analyze and compare the survival of the cardiac arrest victims in&#xD;
      remote areas in the time period when the first responders were not organized yet compared to&#xD;
      the time period when the first responders were activated to perform BLS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2014</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Return of spontaneous circulation (ROSC)</measure>
    <time_frame>5 years</time_frame>
    <description>The number of patients who gained the ROSC.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival to hospital discharge</measure>
    <time_frame>5 years</time_frame>
    <description>The number of patients who survived to hospital discharge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurological outcome</measure>
    <time_frame>5 years</time_frame>
    <description>The number of patients with good neurological outcome assessed with cerebral performance score (CPC 1-2).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival till hospital admission</measure>
    <time_frame>5 years</time_frame>
    <description>The number of patients who survived to hospital admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 day survival</measure>
    <time_frame>5 years</time_frame>
    <description>The number of patients who survived first 30 days after cardiac arrest.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Cardiac Arrest, Sudden</condition>
  <arm_group>
    <arm_group_label>First responder group</arm_group_label>
    <description>Cardiac arrest victims in remote areas resuscitated by the first responders before the arrival of the EMS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EMS groups</arm_group_label>
    <description>Cardiac arrest victims in remote areas resuscitated by the EMS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Basic life support witn use of an AED before EMS</intervention_name>
    <description>BLS performance with use of an AED before arrival of EMS</description>
    <arm_group_label>First responder group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In the study will be included all adult cardiac arrest victims in the remote areas.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cardiac arrest in adult victims&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiac arrest in pediatric population&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Maribor</investigator_affiliation>
    <investigator_full_name>Matej Strnad</investigator_full_name>
    <investigator_title>Assoc. Professor</investigator_title>
  </responsible_party>
  <keyword>cardiac arrest</keyword>
  <keyword>cardiopulmonary resuscitation</keyword>
  <keyword>automated external defibrillator</keyword>
  <keyword>first responders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04485390
org study id: UKC-MB-KME-24/20
nct id: NCT04485390
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Emergency medical services (EMS) provide emergency care not only in the urban but also in the
      remote areas which could be up to 40 minutes from the EMS station. Thus, a cardiac arrest
      victim in those remote areas has a low likelihood to survive the cardiopulmonary
      resuscitation. Therefore, we have organized first responders (who are mostly volunteer
      fire-fighters) in the remote areas and taught them how to perform basic life support (BLS)
      with use of an automated external defibrillator (AED). In the case of a cardiac arrest the
      medical dispatcher activates simultaneously the EMS and the first responders, who perform the
      BLS with the use of an AED before the arrival of EMS.

      The aim of the study is to analyze and compare the survival of the cardiac arrest victims in
      remote areas in the time period when the first responders were not organized yet compared to
      the time period when the first responders were activated to perform BLS.
observational model: Cohort
time perspective: Retrospective
measure: Return of spontaneous circulation (ROSC)
time frame: 5 years
description: The number of patients who gained the ROSC.
measure: Survival to hospital discharge
time frame: 5 years
description: The number of patients who survived to hospital discharge.
measure: Neurological outcome
time frame: 5 years
description: The number of patients with good neurological outcome assessed with cerebral performance score (CPC 1-2).
measure: Survival till hospital admission
time frame: 5 years
description: The number of patients who survived to hospital admission.
measure: 30 day survival
time frame: 5 years
description: The number of patients who survived first 30 days after cardiac arrest.
arm group label: First responder group
description: Cardiac arrest victims in remote areas resuscitated by the first responders before the arrival of the EMS.
arm group label: EMS groups
description: Cardiac arrest victims in remote areas resuscitated by the EMS.
intervention type: Other
intervention name: Basic life support witn use of an AED before EMS
description: BLS performance with use of an AED before arrival of EMS
arm group label: First responder group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: University Medical Centre Maribor
investigator full name: Matej Strnad
investigator title: Assoc. Professor
mesh term: Heart Arrest
mesh term: Death, Sudden, Cardiac
sharing ipd: Undecided