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Use of Public Access Defibrillators by Untrained Bystanders

Primary Purpose

Cardiac Arrest, Sudden Death, Cardiac

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Defibrillator model
Sponsored by
University Hospital Southampton NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Members of the public who have never received any first aid (CPR) training

Exclusion Criteria:

  • Those less than 16 yrs age
  • Those with any physical disability precluding the use of a PAD

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Defibrillator - Model 1

    Defibrillator - Model 2

    Defibrillator - Model 3

    Defibrillator - Model 4

    Defibrillator - Model 5

    Defibrillator - Model 6

    Arm Description

    Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.

    Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.

    Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.

    Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.

    Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.

    Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.

    Outcomes

    Primary Outcome Measures

    Time from arrival at patient side to discharging a defibrillation shock
    Comparison of median time taken to achieve this endpoint for each type of defibrillator

    Secondary Outcome Measures

    Time from arrival at patient side to correct application of self-adhesive defibrillation pads
    Comparison of median time taken to achieve this endpoint for each type of defibrillator
    Following of written and verbal instructions to ensure safe use of device
    % rescuers using each type of defibrillator without causing risk to themselves (as judged by observer)

    Full Information

    First Posted
    July 23, 2017
    Last Updated
    May 8, 2022
    Sponsor
    University Hospital Southampton NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03230773
    Brief Title
    Use of Public Access Defibrillators by Untrained Bystanders
    Official Title
    Can Untrained Bystanders Safely and Effectively Use an Automated External Defibrillator (AED) in a Cardiac Arrest Scenario?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Postponed
    Study Start Date
    April 1, 2020 (Actual)
    Primary Completion Date
    May 1, 2022 (Actual)
    Study Completion Date
    May 1, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital Southampton NHS Foundation Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrest, Sudden Death, Cardiac

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, randomised study with volunteers randomised to use one of six different defibrillator designs.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Defibrillator - Model 1
    Arm Type
    Experimental
    Arm Description
    Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.
    Arm Title
    Defibrillator - Model 2
    Arm Type
    Experimental
    Arm Description
    Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.
    Arm Title
    Defibrillator - Model 3
    Arm Type
    Experimental
    Arm Description
    Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.
    Arm Title
    Defibrillator - Model 4
    Arm Type
    Experimental
    Arm Description
    Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.
    Arm Title
    Defibrillator - Model 5
    Arm Type
    Experimental
    Arm Description
    Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.
    Arm Title
    Defibrillator - Model 6
    Arm Type
    Experimental
    Arm 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(s)
    Defibrillator model
    Intervention Description
    Comparison of the performance of different public access defibrillators
    Primary Outcome Measure Information:
    Title
    Time from arrival at patient side to discharging a defibrillation shock
    Description
    Comparison of median time taken to achieve this endpoint for each type of defibrillator
    Time Frame
    Within the 5 mins of the simulated cardiac arrest.
    Secondary Outcome Measure Information:
    Title
    Time from arrival at patient side to correct application of self-adhesive defibrillation pads
    Description
    Comparison of median time taken to achieve this endpoint for each type of defibrillator
    Time Frame
    Within the 5 mins of the simulated cardiac arrest.
    Title
    Following of written and verbal instructions to ensure safe use of device
    Description
    % rescuers using each type of defibrillator without causing risk to themselves (as judged by observer)
    Time Frame
    Within the 5 mins of the simulated cardiac arrest.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Members of the public who have never received any first aid (CPR) training Exclusion Criteria: Those less than 16 yrs age Those with any physical disability precluding the use of a PAD

    12. IPD Sharing Statement

    Learn more about this trial

    Use of Public Access Defibrillators by Untrained Bystanders

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