<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/NCT03230773</url>
  </required_header>
  <id_info>
    <org_study_id>26783</org_study_id>
    <nct_id>NCT03230773</nct_id>
  </id_info>
  <brief_title>Use of Public Access Defibrillators by Untrained Bystanders</brief_title>
  <official_title>Can Untrained Bystanders Safely and Effectively Use an Automated External Defibrillator (AED) in a Cardiac Arrest Scenario?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Southampton NHS Foundation Trust</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>
      Survival from out-of-hospital cardiac arrest is time critical and diminishes rapidly without&#xD;
      appropriate intervention. Bystander CPR at least doubles the chances of survival and the&#xD;
      additional use of a public access defibrillator (PAD) can again double overall survival&#xD;
      rates. PADs are designed to be easy and simple to use, but whether untrained bystanders can&#xD;
      use them safely and effectively is unknown. This study will aim to assess the ability of&#xD;
      untrained bystanders to deploy a PAD in a simulated cardiac arrest.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Survival from out-of-hospital cardiac arrest is time critical and diminishes rapidly without&#xD;
      appropriate intervention. Overall survival is no more than 10% in the UK.&#xD;
&#xD;
      Bystander CPR at least doubles the chances of survival and the additional use of a public&#xD;
      access defibrillator (PAD) can again double overall survival rates. Because PADs can make&#xD;
      such a dramatic increase in chances of survival, public health programmes have encouraged the&#xD;
      deployment of PADs in areas of high public density in order to deliver early defibrillation&#xD;
      prior to ambulance arrival. Where this can be achieved, survival rates as high as 50% have&#xD;
      been reported.&#xD;
&#xD;
      PADs are designed to be easy and simple to use, and in addition to graphical instructions on&#xD;
      the device, give verbal instructions to a rescuer in order to ensure the PAD is used&#xD;
      correctly. Most bystanders who are first on scene at a cardiac arrest have no first aid&#xD;
      training and it is not always possible to wait for someone with first aid training to be&#xD;
      available to use a PAD. Several guidelines, such as those from the Resuscitation Council&#xD;
      (UK), state that untrained bystanders can use a PAD, but there has been little evaluation to&#xD;
      understand whether this can safely and effectively be achieved without specific PAD training.&#xD;
&#xD;
      This study will aim to assess the ability of untrained bystanders to safely and effectively&#xD;
      deploy a PAD in a simulated cardiac arrest, specifically aiming to identify differences&#xD;
      between the features of different devices that improve their ease of use in order to&#xD;
      understand what design features are required for optimal design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Postponed&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Actual">May 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 2022</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>
    <intervention_model_description>Prospective, randomised study with volunteers randomised to use one of six different defibrillator designs.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time from arrival at patient side to discharging a defibrillation shock</measure>
    <time_frame>Within the 5 mins of the simulated cardiac arrest.</time_frame>
    <description>Comparison of median time taken to achieve this endpoint for each type of defibrillator</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from arrival at patient side to correct application of self-adhesive defibrillation pads</measure>
    <time_frame>Within the 5 mins of the simulated cardiac arrest.</time_frame>
    <description>Comparison of median time taken to achieve this endpoint for each type of defibrillator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Following of written and verbal instructions to ensure safe use of device</measure>
    <time_frame>Within the 5 mins of the simulated cardiac arrest.</time_frame>
    <description>% rescuers using each type of defibrillator without causing risk to themselves (as judged by observer)</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cardiac Arrest</condition>
  <condition>Sudden Death, Cardiac</condition>
  <arm_group>
    <arm_group_label>Defibrillator - Model 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Defibrillator - Model 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Defibrillator - Model 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Defibrillator - Model 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Defibrillator - Model 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Defibrillator - Model 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Defibrillator model</intervention_name>
    <description>Comparison of the performance of different public access defibrillators</description>
    <arm_group_label>Defibrillator - Model 1</arm_group_label>
    <arm_group_label>Defibrillator - Model 2</arm_group_label>
    <arm_group_label>Defibrillator - Model 3</arm_group_label>
    <arm_group_label>Defibrillator - Model 4</arm_group_label>
    <arm_group_label>Defibrillator - Model 5</arm_group_label>
    <arm_group_label>Defibrillator - Model 6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Members of the public who have never received any first aid (CPR) training&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those less than 16 yrs age&#xD;
&#xD;
          -  Those with any physical disability precluding the use of a PAD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>May 8, 2022</last_update_submitted>
  <last_update_submitted_qc>May 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Southampton NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Charles D. Deakin</investigator_full_name>
    <investigator_title>Professor of Resuscitation</investigator_title>
  </responsible_party>
  <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>
    <mesh_term>Death, Sudden</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <!-- 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/NCT03230773
org study id: 26783
nct id: NCT03230773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Survival from out-of-hospital cardiac arrest is time critical and diminishes rapidly without
      appropriate intervention. Bystander CPR at least doubles the chances of survival and the
      additional use of a public access defibrillator (PAD) can again double overall survival
      rates. PADs are designed to be easy and simple to use, but whether untrained bystanders can
      use them safely and effectively is unknown. This study will aim to assess the ability of
      untrained bystanders to deploy a PAD in a simulated cardiac arrest.
Survival from out-of-hospital cardiac arrest is time critical and diminishes rapidly without
      appropriate intervention. Overall survival is no more than 10% in the UK.

      Bystander CPR at least doubles the chances of survival and the additional use of a public
      access defibrillator (PAD) can again double overall survival rates. Because PADs can make
      such a dramatic increase in chances of survival, public health programmes have encouraged the
      deployment of PADs in areas of high public density in order to deliver early defibrillation
      prior to ambulance arrival. Where this can be achieved, survival rates as high as 50% have
      been reported.

      PADs are designed to be easy and simple to use, and in addition to graphical instructions on
      the device, give verbal instructions to a rescuer in order to ensure the PAD is used
      correctly. Most bystanders who are first on scene at a cardiac arrest have no first aid
      training and it is not always possible to wait for someone with first aid training to be
      available to use a PAD. Several guidelines, such as those from the Resuscitation Council
      (UK), state that untrained bystanders can use a PAD, but there has been little evaluation to
      understand whether this can safely and effectively be achieved without specific PAD training.

      This study will aim to assess the ability of untrained bystanders to safely and effectively
      deploy a PAD in a simulated cardiac arrest, specifically aiming to identify differences
      between the features of different devices that improve their ease of use in order to
      understand what design features are required for optimal design.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomised study with volunteers randomised to use one of six different defibrillator designs.
primary purpose: Treatment
masking: None (Open Label)
measure: Time from arrival at patient side to discharging a defibrillation shock
time frame: Within the 5 mins of the simulated cardiac arrest.
description: Comparison of median time taken to achieve this endpoint for each type of defibrillator
measure: Time from arrival at patient side to correct application of self-adhesive defibrillation pads
time frame: Within the 5 mins of the simulated cardiac arrest.
description: Comparison of median time taken to achieve this endpoint for each type of defibrillator
measure: Following of written and verbal instructions to ensure safe use of device
time frame: Within the 5 mins of the simulated cardiac arrest.
description: % rescuers using each type of defibrillator without causing risk to themselves (as judged by observer)
arm group label: Defibrillator - Model 1
arm group type: Experimental
description: Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.
arm group label: Defibrillator - Model 2
arm group type: Experimental
description: Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.
arm group label: Defibrillator - Model 3
arm group type: Experimental
description: Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.
arm group label: Defibrillator - Model 4
arm group type: Experimental
description: Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.
arm group label: Defibrillator - Model 5
arm group type: Experimental
description: Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.
arm group label: Defibrillator - Model 6
arm group type: Experimental
description: Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.
intervention type: Device
intervention name: Defibrillator model
description: Comparison of the performance of different public access defibrillators
arm group label: Defibrillator - Model 1
arm group label: Defibrillator - Model 2
arm group label: Defibrillator - Model 3
arm group label: Defibrillator - Model 4
arm group label: Defibrillator - Model 5
arm group label: Defibrillator - Model 6
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University Hospital Southampton NHS Foundation Trust
investigator full name: Charles D. Deakin
investigator title: Professor of Resuscitation
mesh term: Heart Arrest
mesh term: Death, Sudden, Cardiac
mesh term: Death, Sudden
mesh term: Death