xml: <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/NCT06016153</url>
    </required_header>
    <id_info>
      <org_study_id>SUVM_BLS_1</org_study_id>
      <nct_id>NCT06016153</nct_id>
    </id_info>
    <brief_title>The Efficacy of Basic Life Support Education Among Teenagers</brief_title>
    <acronym>BLSGimiHun</acronym>
    <official_title>The Investigation of the Efficacy of Basic Life Support Education Among High School Students</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Semmelweis University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Semmelweis University</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>
        Basic life support (BLS) skills are crucial not only for healthcare workers but for all lay&#xD;
        people as well. Timely recognition of out-of-hospital cardiac arrest and the initiation of&#xD;
        BLS by bystanders before the arrival of healthcare personnel can improve survival.&#xD;
  &#xD;
        There are several methods of spreading BLS skills and improve BLS skill retention among lay&#xD;
        people. One of these methods can be educating school children. The introduction of mandatory&#xD;
        BLS education in schools was very effective in some European countries to increase the rate&#xD;
        of bystander BLS.&#xD;
  &#xD;
        The current study aims to investigate the efficacy of a BLS training and BLS curriculum among&#xD;
        high school children in Hungary. Moreover, the investigators would like to optimise factors&#xD;
        influencing skill retention in this first responder group and aim to compare two types of&#xD;
        teaching methods: feedback given by the instructor or software-based feedback on the efficacy&#xD;
        of chest compressions during the course.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 8, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>End of training BLS skill assessment based on a checklist</measure>
      <time_frame>up to two hours</time_frame>
      <description>BLS skills measured right after the training based on a checklist including the most important steps of BLS and quality of chest compression. The assessment will be performed by one or two instructors and the built-in software of Ambu Man C torso.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>BLS skill assessment after 2 months based on a checklist</measure>
      <time_frame>2 months</time_frame>
      <description>BLS skills measured 2 months after the training based on a checklist including the most important steps of BLS and quality of chest compression. The assessment will be performed by one or two instructors and the built-in software of Ambu Man C torso.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BLS skill assessment after 6 months based on a checklist</measure>
      <time_frame>6 months</time_frame>
      <description>BLS skills measured 6 months after the training based on a checklist including the most important steps of BLS and quality of chest compression. The assessment will be performed by one or two instructors and the built-in software of Ambu Man C torso.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">360</enrollment>
    <condition>Cardiopulmonary Resuscitation</condition>
    <condition>Basic Life Support</condition>
    <condition>Premedical Education</condition>
    <condition>Study Skills</condition>
    <arm_group>
      <arm_group_label>Instructor feedback</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>BLS training participants will receive feedback from an experienced instructor certified by European Resuscitation Council on the depth and frequency of chest compressions, duty cycle, chest recoil and the quality of ventilation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Software feedback</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BLS training participants will receive feedback based on a software built in the Ambu Man C Torso (Ambu A/S, Copenhagen, Debmark) on the quality of chest compression (exact frequency, depth of chest compression, chest recoil and duty cycle) and tidal volume during ventilation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Software based feedback</intervention_name>
      <description>Feedback is given by the data of a software built in Ambu Man C Torso (Ambu A/S, Copenhagen, Denmark).</description>
      <arm_group_label>Software feedback</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Instructor feedback</intervention_name>
      <description>Feedback is given by the opinion and observation of an experienced instructor.</description>
      <arm_group_label>Instructor feedback</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  High school teenagers participating in the education of Óbudai High School, Budapest&#xD;
  &#xD;
            -  Written informed consent received from participants and their parents to participate&#xD;
               in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No written informed consent provided by the student or parent&#xD;
  &#xD;
            -  Any injury or health issue influencing the efficacy of BLS skill&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>19 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Endre Zima, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Semmelweis University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Uzonka Szabolcsi</last_name>
      <phone>+361458680</phone>
      <email>szabolcsiu@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Enikő Kovács, PhD</last_name>
      <phone>+36206632035</phone>
      <email>kovacs.eniko2@med.semmelweis-univ.hu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016153
  org study id: SUVM_BLS_1
  nct id: NCT06016153
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Basic life support (BLS) skills are crucial not only for healthcare workers but for all lay
        people as well. Timely recognition of out-of-hospital cardiac arrest and the initiation of
        BLS by bystanders before the arrival of healthcare personnel can improve survival.
  
        There are several methods of spreading BLS skills and improve BLS skill retention among lay
        people. One of these methods can be educating school children. The introduction of mandatory
        BLS education in schools was very effective in some European countries to increase the rate
        of bystander BLS.
  
        The current study aims to investigate the efficacy of a BLS training and BLS curriculum among
        high school children in Hungary. Moreover, the investigators would like to optimise factors
        influencing skill retention in this first responder group and aim to compare two types of
        teaching methods: feedback given by the instructor or software-based feedback on the efficacy
        of chest compressions during the course.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: End of training BLS skill assessment based on a checklist
  time frame: up to two hours
  description: BLS skills measured right after the training based on a checklist including the most important steps of BLS and quality of chest compression. The assessment will be performed by one or two instructors and the built-in software of Ambu Man C torso.
  measure: BLS skill assessment after 2 months based on a checklist
  time frame: 2 months
  description: BLS skills measured 2 months after the training based on a checklist including the most important steps of BLS and quality of chest compression. The assessment will be performed by one or two instructors and the built-in software of Ambu Man C torso.
  measure: BLS skill assessment after 6 months based on a checklist
  time frame: 6 months
  description: BLS skills measured 6 months after the training based on a checklist including the most important steps of BLS and quality of chest compression. The assessment will be performed by one or two instructors and the built-in software of Ambu Man C torso.
  arm group label: Instructor feedback
  arm group type: Active Comparator
  description: BLS training participants will receive feedback from an experienced instructor certified by European Resuscitation Council on the depth and frequency of chest compressions, duty cycle, chest recoil and the quality of ventilation.
  arm group label: Software feedback
  arm group type: Experimental
  description: BLS training participants will receive feedback based on a software built in the Ambu Man C Torso (Ambu A/S, Copenhagen, Debmark) on the quality of chest compression (exact frequency, depth of chest compression, chest recoil and duty cycle) and tidal volume during ventilation.
  intervention type: Other
  intervention name: Software based feedback
  description: Feedback is given by the data of a software built in Ambu Man C Torso (Ambu A/S, Copenhagen, Denmark).
  arm group label: Software feedback
  intervention type: Other
  intervention name: Instructor feedback
  description: Feedback is given by the opinion and observation of an experienced instructor.
  arm group label: Instructor feedback
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 19 Years
  healthy volunteers: No
  last name: Endre Zima, PhD
  role: Principal Investigator
  affiliation: Semmelweis University
  last name: Uzonka Szabolcsi
  phone: +361458680
  email: szabolcsiu@gmail.com
  last name: Enikő Kovács, PhD
  phone: +36206632035
  email: kovacs.eniko2@med.semmelweis-univ.hu
  responsible party type: Sponsor