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/NCT05992454</url>
    </required_header>
    <id_info>
      <org_study_id>2022-A02771-42</org_study_id>
      <nct_id>NCT05992454</nct_id>
    </id_info>
    <brief_title>Ventilation in Cardiac Arrest Resuscitation Study</brief_title>
    <acronym>VECARS</acronym>
    <official_title>An Evaluation of Manual Ventilation Practices of Professional Firefighters During Cardiopulmonary Resuscitation.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>French Defence Health Service</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fire Brigade Of Paris Emergency Medicine Dept</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>French Defence Health Service</source>
    <oversight_info>
      <has_dmc>No</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>
        Out-of-hospital cardiac arrest (OHCA) is a major public health problem, with around 40,000&#xD;
        victims each year in France. Their survival rate remains dramatically low, at less than 10%.&#xD;
  &#xD;
        In the event of pre-hospital cardiac arrest, rescuers perform resuscitation techniques using&#xD;
        equipment for which they have been trained. They perform cardiopulmonary resuscitation (CPR)&#xD;
        by alternating 30 chest compressions with 2 insufflations (30/2) with a manual insufflator&#xD;
        bag.&#xD;
  &#xD;
        In basic life supports, insufflations should result in chest rise, but guidelines do not&#xD;
        specify a precise volume.&#xD;
  &#xD;
        Recently, medical devices have been developed that enable precise measurement of ventilatory&#xD;
        volumes. In simulation, these devices show hyperventilation in volume and frequency in&#xD;
        mannequins. But no clinical study has analyzed insufflator bag ventilation maneuvers in&#xD;
        real-life situations on pre-hospital cardiac arrest patients.&#xD;
  &#xD;
        The aim of this study is to analyze ventilation parameters in current practice in relation to&#xD;
        standards, and the factors influencing the quality of ventilation maneuvers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 26, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Tidal volume</measure>
      <time_frame>up to 20 minutes (end of BLS-CPR)</time_frame>
      <description>Measurement of lung volume (mL) received [air + oxygen] for each manual insufflation performed by the rescuer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>chest rise</measure>
      <time_frame>up to 20 minutes (end of BLS-CPR)</time_frame>
      <description>concomitant chest rise (YES/NO) during each ventilation procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ventilation rate</measure>
      <time_frame>up to 20 minutes (end of BLS-CPR)</time_frame>
      <description>Ventilation rate per min. achieved by the rescuer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insufflation time</measure>
      <time_frame>up to 20 minutes (end of BLS-CPR)</time_frame>
      <description>Insufflation time (seconds) per ventilation procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Face mask leakage</measure>
      <time_frame>up to 20 minutes (end of BLS-CPR)</time_frame>
      <description>face mask leakage per ventilation procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume delivered by the rescuer</measure>
      <time_frame>up to 20 minutes (end of BLS-CPR)</time_frame>
      <description>Volume delivered (mL) by the rescuer per ventilation procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival to day 30 after cardiac arrest</measure>
      <time_frame>up to 30 days</time_frame>
      <description>Survival curve over the first 30 days</description>
    </secondary_outcome>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Heart Arrest, Out-Of-Hospital</condition>
    <condition>CardioPulmonary Resuscitation</condition>
    <condition>Basic Cardiac Life Support</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EOLIFE</intervention_name>
      <description>Measurement of ventilatory parameters during manual ventilation by professional rescuers during out-of-hospital cardiac arrest</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Civilian population in hyperurban areas&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Out of hospital cardiac arrest with CPR performed by the Firefighters&#xD;
  &#xD;
            -  Age 18 and over&#xD;
  &#xD;
            -  BLS team on site before arrival of physician staffed ALS means&#xD;
  &#xD;
            -  CPR ventilation initially provided with Bag-valve- mask&#xD;
  &#xD;
            -  Measuring device records ventilatory parameters&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  trauma related OHCA&#xD;
  &#xD;
            -  airway obstruction during CPR&#xD;
  &#xD;
            -  OHCA on hanging&#xD;
  &#xD;
            -  tracheostomized patient&#xD;
  &#xD;
            -  obstacle to using the Bag-valve-mask&#xD;
  &#xD;
            -  CPR time less than 2 minutes&#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>Frederic Lemoine, NP</last_name>
      <role>Principal Investigator</role>
      <affiliation>Paris Fire Brigade Emergency Dept</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Stephane Travers, MD PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Paris Fire Brigade Emergency Dept</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Frederic Lemoine, NP</last_name>
      <phone>0033156796753</phone>
      <email>frederic.lemoine@pompiersparis.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Daniel Jost, MD</last_name>
      <phone>0033156796753</phone>
      <email>daniel.jost@pompiersparis.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Paris Fire Brigade</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Frederic Lemoine, NP</last_name>
        <phone>0033156796753</phone>
        <email>frederic.lemoine@pompiersparis.fr</email>
      </contact>
      <contact_backup>
        <last_name>Daniel Jost, MD</last_name>
        <phone>0033156796753</phone>
        <email>daniel.jost@pompiersparis.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fire Brigade Of Paris Emergency Medicine Dept</investigator_affiliation>
      <investigator_full_name>Daniel Jost</investigator_full_name>
      <investigator_title>Physician heading the scientific section</investigator_title>
    </responsible_party>
    <keyword>heart arrest</keyword>
    <keyword>cardiopulmonary resuscitation</keyword>
    <keyword>bag-valve-mask</keyword>
    <keyword>rescuers</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>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05992454
  org study id: 2022-A02771-42
  nct id: NCT05992454
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Out-of-hospital cardiac arrest (OHCA) is a major public health problem, with around 40,000
        victims each year in France. Their survival rate remains dramatically low, at less than 10%.
  
        In the event of pre-hospital cardiac arrest, rescuers perform resuscitation techniques using
        equipment for which they have been trained. They perform cardiopulmonary resuscitation (CPR)
        by alternating 30 chest compressions with 2 insufflations (30/2) with a manual insufflator
        bag.
  
        In basic life supports, insufflations should result in chest rise, but guidelines do not
        specify a precise volume.
  
        Recently, medical devices have been developed that enable precise measurement of ventilatory
        volumes. In simulation, these devices show hyperventilation in volume and frequency in
        mannequins. But no clinical study has analyzed insufflator bag ventilation maneuvers in
        real-life situations on pre-hospital cardiac arrest patients.
  
        The aim of this study is to analyze ventilation parameters in current practice in relation to
        standards, and the factors influencing the quality of ventilation maneuvers.
  observational model: Cohort
  time perspective: Prospective
  measure: Tidal volume
  time frame: up to 20 minutes (end of BLS-CPR)
  description: Measurement of lung volume (mL) received [air + oxygen] for each manual insufflation performed by the rescuer
  measure: chest rise
  time frame: up to 20 minutes (end of BLS-CPR)
  description: concomitant chest rise (YES/NO) during each ventilation procedure
  measure: Ventilation rate
  time frame: up to 20 minutes (end of BLS-CPR)
  description: Ventilation rate per min. achieved by the rescuer
  measure: Insufflation time
  time frame: up to 20 minutes (end of BLS-CPR)
  description: Insufflation time (seconds) per ventilation procedure
  measure: Face mask leakage
  time frame: up to 20 minutes (end of BLS-CPR)
  description: face mask leakage per ventilation procedure
  measure: Volume delivered by the rescuer
  time frame: up to 20 minutes (end of BLS-CPR)
  description: Volume delivered (mL) by the rescuer per ventilation procedure
  measure: Survival to day 30 after cardiac arrest
  time frame: up to 30 days
  description: Survival curve over the first 30 days
  intervention type: Device
  intervention name: EOLIFE
  description: Measurement of ventilatory parameters during manual ventilation by professional rescuers during out-of-hospital cardiac arrest
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Frederic Lemoine, NP
  role: Principal Investigator
  affiliation: Paris Fire Brigade Emergency Dept
  last name: Stephane Travers, MD PhD
  role: Study Chair
  affiliation: Paris Fire Brigade Emergency Dept
  last name: Frederic Lemoine, NP
  phone: 0033156796753
  email: frederic.lemoine@pompiersparis.fr
  last name: Daniel Jost, MD
  phone: 0033156796753
  email: daniel.jost@pompiersparis.fr
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: Fire Brigade Of Paris Emergency Medicine Dept
  investigator full name: Daniel Jost
  investigator title: Physician heading the scientific section
  mesh term: Heart Arrest
  mesh term: Out-of-Hospital Cardiac Arrest
  sharing ipd: Undecided