<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/NCT01718795</url>
  </required_header>
  <id_info>
    <org_study_id>Prehospital LTS vs. BVM</org_study_id>
    <nct_id>NCT01718795</nct_id>
  </id_info>
  <brief_title>Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR</brief_title>
  <official_title>Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR- A Prospective, Controlled, Randomised, Multi-center Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael Baubin, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During CPR bag-valve mask ventilation is difficult for basically skilled rescuers.&#xD;
      Ventilation may be inefficient or with too high pressures result in stomach inflation and&#xD;
      aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal&#xD;
      tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital&#xD;
      study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR.&#xD;
      Thus, this study intends to compare ventilation with laryngeal tube and bag-valve mask&#xD;
      performed by paramedics during CPR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During CPR bag-valve mask ventilation is difficult for basically skilled rescuers.&#xD;
      Ventilation may be inefficient or with too high pressures result in stomach inflation and&#xD;
      aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal&#xD;
      tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital&#xD;
      study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR.&#xD;
      This study intends to compare ventilation with laryngeal tube and bag-valve mask performed by&#xD;
      paramedics during CPR. This study may provide information if paramedics in an emergency&#xD;
      should ventilate as they do traditionally with bag-valve mask ventilation or if they should&#xD;
      ventilate with a laryngeal tube.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruiting too slow, down to 1-0 patients per month&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficient ventilation</measure>
    <time_frame>From start of paramedic ventilating the patient during CPR until emergency physician takes over ventilation or patient breathes again spontaneously after return of spontaneous circulation (ROSC)</time_frame>
    <description>Does chest rise clearly during CPR? Thus efficient ventilation will be assessed during CPR, which may last on average between 20 and 60min. Therefore efficient ventilation will be assessed from starting CPR at 0min to 20min or rarely 60min or longer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aspiration</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month after enrollment of the last patient at August 30th 2014</time_frame>
    <description>Aspiration will be assessed 24hrs after CPR with bronchoscopy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Cardiac Arrest During and/or Resulting From A Procedure</condition>
  <arm_group>
    <arm_group_label>Bag-valve mask ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bag-valve mask ventilation during CPR, i.e. traditional ventilation during CPR. Airway management with bag-valve mask ventilation and efficient ventilation: yes or no?&#xD;
Intervention is &quot;Bag-valve mask ventilation&quot; during CPR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laryngeal Tube</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laryngeal Tube Ventilation during CPR, i.e. the alternative ventilation technique to be compared to the traditional technique. Airway management with laryngeal tube and efficient ventilation: yes or no?&#xD;
Intervention is &quot;Ventilation through laryngeal tube&quot; during CPR</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bag-valve mask or laryngeal tube ventilation</intervention_name>
    <description>Interventions are either &quot;Bag-valve mask (BVM)&quot; or &quot;Laryngeal tube (LT)&quot; ventilation during CPR</description>
    <arm_group_label>Bag-valve mask ventilation</arm_group_label>
    <arm_group_label>Laryngeal Tube</arm_group_label>
    <other_name>BVM(Ambu,Germany);LT(VBM Medizintechnik,Germany)ventilation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cardiac arrest&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Paramedic does not want to use laryngeal tube&#xD;
&#xD;
          -  Physician on site before paramedic&#xD;
&#xD;
          -  Foreign body airway obstruction&#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>Michael Baubin, Prof. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Innsbruck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <link>
    <url>http://www2.i-med.ac.at/anaesthesie/</url>
    <description>Departement of Anesthesiology and Critical Care Medicine Innsbruck, where study investigators belong to</description>
  </link>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>June 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>March 23, 2016</last_update_submitted>
  <last_update_submitted_qc>March 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medical University Innsbruck</investigator_affiliation>
    <investigator_full_name>Michael Baubin, MD</investigator_full_name>
    <investigator_title>Prof. MD</investigator_title>
  </responsible_party>
  <keyword>Airway</keyword>
  <keyword>Cardiac Arrest</keyword>
  <keyword>CPR</keyword>
  <keyword>Ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT01718795
org study id: Prehospital LTS vs. BVM
nct id: NCT01718795
lead sponsor: 
has dmc: No
During CPR bag-valve mask ventilation is difficult for basically skilled rescuers.
      Ventilation may be inefficient or with too high pressures result in stomach inflation and
      aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal
      tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital
      study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR.
      Thus, this study intends to compare ventilation with laryngeal tube and bag-valve mask
      performed by paramedics during CPR.
During CPR bag-valve mask ventilation is difficult for basically skilled rescuers.
      Ventilation may be inefficient or with too high pressures result in stomach inflation and
      aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal
      tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital
      study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR.
      This study intends to compare ventilation with laryngeal tube and bag-valve mask performed by
      paramedics during CPR. This study may provide information if paramedics in an emergency
      should ventilate as they do traditionally with bag-valve mask ventilation or if they should
      ventilate with a laryngeal tube.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficient ventilation
time frame: From start of paramedic ventilating the patient during CPR until emergency physician takes over ventilation or patient breathes again spontaneously after return of spontaneous circulation (ROSC)
description: Does chest rise clearly during CPR? Thus efficient ventilation will be assessed during CPR, which may last on average between 20 and 60min. Therefore efficient ventilation will be assessed from starting CPR at 0min to 20min or rarely 60min or longer.
measure: Aspiration
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month after enrollment of the last patient at August 30th 2014
description: Aspiration will be assessed 24hrs after CPR with bronchoscopy
arm group label: Bag-valve mask ventilation
arm group type: Active Comparator
description: Bag-valve mask ventilation during CPR, i.e. traditional ventilation during CPR. Airway management with bag-valve mask ventilation and efficient ventilation: yes or no?
Intervention is "Bag-valve mask ventilation" during CPR
arm group label: Laryngeal Tube
arm group type: Active Comparator
description: Laryngeal Tube Ventilation during CPR, i.e. the alternative ventilation technique to be compared to the traditional technique. Airway management with laryngeal tube and efficient ventilation: yes or no?
Intervention is "Ventilation through laryngeal tube" during CPR
intervention type: Device
intervention name: Bag-valve mask or laryngeal tube ventilation
description: Interventions are either "Bag-valve mask (BVM)" or "Laryngeal tube (LT)" ventilation during CPR
arm group label: Bag-valve mask ventilation
arm group label: Laryngeal Tube
other name: BVM(Ambu,Germany);LT(VBM Medizintechnik,Germany)ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Baubin, Prof. MD
role: Principal Investigator
affiliation: Medical University Innsbruck
facility: 
country: Austria
url: http://www2.i-med.ac.at/anaesthesie/
description: Departement of Anesthesiology and Critical Care Medicine Innsbruck, where study investigators belong to
responsible party type: Sponsor-Investigator
investigator affiliation: Medical University Innsbruck
investigator full name: Michael Baubin, MD
investigator title: Prof. MD
mesh term: Heart Arrest
sharing ipd: Yes