Use of Public Access Defibrillators by Untrained Bystanders

NCT ID: NCT03230773

Last Updated: 2022-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2022-05-01

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest Sudden Death, Cardiac

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomised study with volunteers randomised to use one of six different defibrillator designs.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Defibrillator - Model 1

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

Group Type EXPERIMENTAL

Defibrillator model

Intervention Type DEVICE

Comparison of the performance of different public access defibrillators

Defibrillator - Model 2

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

Group Type EXPERIMENTAL

Defibrillator model

Intervention Type DEVICE

Comparison of the performance of different public access defibrillators

Defibrillator - Model 3

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

Group Type EXPERIMENTAL

Defibrillator model

Intervention Type DEVICE

Comparison of the performance of different public access defibrillators

Defibrillator - Model 4

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

Group Type EXPERIMENTAL

Defibrillator model

Intervention Type DEVICE

Comparison of the performance of different public access defibrillators

Defibrillator - Model 5

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

Group Type EXPERIMENTAL

Defibrillator model

Intervention Type DEVICE

Comparison of the performance of different public access defibrillators

Defibrillator - Model 6

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

Group Type EXPERIMENTAL

Defibrillator model

Intervention Type DEVICE

Comparison of the performance of different public access defibrillators

Interventions

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Defibrillator model

Comparison of the performance of different public access defibrillators

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Charles D. Deakin

Professor of Resuscitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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26783

Identifier Type: -

Identifier Source: org_study_id

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