<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/NCT03771911</url>
  </required_header>
  <id_info>
    <org_study_id>QRCP</org_study_id>
    <nct_id>NCT03771911</nct_id>
  </id_info>
  <brief_title>Quality of Cardiopulmonary Resuscitation Guided by AED vs Telephone-assistance</brief_title>
  <acronym>QRCP</acronym>
  <official_title>Quality of Cardiopulmonary Resuscitation Guided by AED vs Telephone-assistance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bionorte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of the Basque Country (UPV/EHU)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Osakidetza</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bionorte</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>
      The aim of this research is to evaluate and to compare the quality of cardiopulmonary&#xD;
      resuscitation (CPR) among untrained laypeople under two different scenarios: automated&#xD;
      external defibrillator (AED) guided CPR or dispatcher-assisted CPR. Secondarily, to evaluate&#xD;
      the quality of the dispatcher-assisted instructions provided from the emergency call center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A simulation study will beperformed. 42 volunteers selected by non-probabilistic sampling&#xD;
      will be randomized in two scenarios of cardiac arrest on mannequin: (A) AED-guided CPR and&#xD;
      (T) dispatcher-assisted CPR. Simulations last 9 minutes. The quality of CPR will be evaluated&#xD;
      by metric monitoring of the chest compressions and timing of actions. A peer's content&#xD;
      analysis of the telephone instructions will be performed using a checklist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Actual">May 27, 2019</completion_date>
  <primary_completion_date type="Actual">April 19, 2019</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>Cardiopulmonary resuscitations strated</measure>
    <time_frame>9 minutes</time_frame>
    <description>nº of CPR strated by bystander</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chest compressions rate</measure>
    <time_frame>9 minutes</time_frame>
    <description>Chest compression/minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chest compressions depth/recoil</measure>
    <time_frame>9 minutes</time_frame>
    <description>% os chest compressions with correct depth/recoil</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time under CPR</measure>
    <time_frame>8 minutes</time_frame>
    <description>% of time applying chest compressions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hands on chest</measure>
    <time_frame>9 minutes</time_frame>
    <description>% of chest compressions with a correct position of hands</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Cardiopulmonary Resuscitation</condition>
  <arm_group>
    <arm_group_label>AED guided</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Laypeople will be guided by an Automatic External Defibrillator's (AED) voice instructions during the cardiopulmonary resuscitation.&#xD;
No other help is available.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telephone guided</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Laypeople will be guided by telephone assistance (from an Emergency Call Center) during the cardiopulmonary resuscitation.&#xD;
AED voice instructions are also available.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AED</intervention_name>
    <description>Instructions provided by an AED</description>
    <arm_group_label>AED guided</arm_group_label>
    <arm_group_label>Telephone guided</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telephone</intervention_name>
    <description>Instructions provided by emergency Call Center (telephonically) with the help of an AED.</description>
    <arm_group_label>Telephone guided</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  untrained laypeople&#xD;
&#xD;
          -  Volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnants, leg/arm injuried people, chronic back pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irrintzi Fernández-Aedo, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of the Basque Country (UPV/EHU)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gorka Vallejo-De la Hoz, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Osakidetza</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alejandro Etayo-Sancho, RN</last_name>
    <role>Study Chair</role>
    <affiliation>Ambuiberica</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Asier Alonso-Pinillos, RN</last_name>
    <role>Study Chair</role>
    <affiliation>Osakidetza</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sendoa Ballesteros-Peña, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Osakidetza</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Basurto</name>
      <address>
        <city>Bilbao</city>
        <state>Bizkaia</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>September 26, 2019</last_update_submitted>
  <last_update_submitted_qc>September 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03771911
org study id: QRCP
nct id: NCT03771911
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this research is to evaluate and to compare the quality of cardiopulmonary
      resuscitation (CPR) among untrained laypeople under two different scenarios: automated
      external defibrillator (AED) guided CPR or dispatcher-assisted CPR. Secondarily, to evaluate
      the quality of the dispatcher-assisted instructions provided from the emergency call center.
A simulation study will beperformed. 42 volunteers selected by non-probabilistic sampling
      will be randomized in two scenarios of cardiac arrest on mannequin: (A) AED-guided CPR and
      (T) dispatcher-assisted CPR. Simulations last 9 minutes. The quality of CPR will be evaluated
      by metric monitoring of the chest compressions and timing of actions. A peer's content
      analysis of the telephone instructions will be performed using a checklist.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cardiopulmonary resuscitations strated
time frame: 9 minutes
description: nº of CPR strated by bystander
measure: Chest compressions rate
time frame: 9 minutes
description: Chest compression/minute
measure: Chest compressions depth/recoil
time frame: 9 minutes
description: % os chest compressions with correct depth/recoil
measure: Time under CPR
time frame: 8 minutes
description: % of time applying chest compressions
measure: Hands on chest
time frame: 9 minutes
description: % of chest compressions with a correct position of hands
arm group label: AED guided
arm group type: Other
description: Laypeople will be guided by an Automatic External Defibrillator's (AED) voice instructions during the cardiopulmonary resuscitation.
No other help is available.
arm group label: Telephone guided
arm group type: Other
description: Laypeople will be guided by telephone assistance (from an Emergency Call Center) during the cardiopulmonary resuscitation.
AED voice instructions are also available.
intervention type: Device
intervention name: AED
description: Instructions provided by an AED
arm group label: AED guided
arm group label: Telephone guided
intervention type: Device
intervention name: Telephone
description: Instructions provided by emergency Call Center (telephonically) with the help of an AED.
arm group label: Telephone guided
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Irrintzi Fernández-Aedo, PhD
role: Study Chair
affiliation: University of the Basque Country (UPV/EHU)
last name: Gorka Vallejo-De la Hoz, PhD
role: Study Chair
affiliation: Osakidetza
last name: Alejandro Etayo-Sancho, RN
role: Study Chair
affiliation: Ambuiberica
last name: Asier Alonso-Pinillos, RN
role: Study Chair
affiliation: Osakidetza
last name: Sendoa Ballesteros-Peña, PhD
role: Study Director
affiliation: Osakidetza
facility: 
country: Spain
responsible party type: Sponsor
sharing ipd: No