Use of Public Access Defibrillators by Untrained Bystanders

Can Untrained Bystanders Safely and Effectively Use an Automated External Defibrillator (AED) in a Cardiac Arrest Scenario?

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiac Arrest; Sudden Death, Cardiac
• Intervention / Treatment: Device: Defibrillator model

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Defibrillator - Model 1; Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.	Device: Defibrillator model; Comparison of the performance of different public access defibrillators
EXPERIMENTAL: Defibrillator - Model 2; Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.	Device: Defibrillator model; Comparison of the performance of different public access defibrillators
EXPERIMENTAL: Defibrillator - Model 3; Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.	Device: Defibrillator model; Comparison of the performance of different public access defibrillators
EXPERIMENTAL: Defibrillator - Model 4; Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.	Device: Defibrillator model; Comparison of the performance of different public access defibrillators
EXPERIMENTAL: Defibrillator - Model 5; Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.	Device: Defibrillator model; Comparison of the performance of different public access defibrillators
EXPERIMENTAL: Defibrillator - Model 6; Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario.	Device: Defibrillator model; Comparison of the performance of different public access defibrillators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within the 5 mins of the simulated cardiac arrest.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within the 5 mins of the simulated cardiac arrest.
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)	Within the 5 mins of the simulated cardiac arrest.

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2020
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): May 1, 2022

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (ACTUAL): July 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 8, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death; Heart Arrest; Death, Sudden, Cardiac; Death, Sudden
• Other Study ID Numbers: 26783

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No