Use of Public Access Defibrillators by Untrained Bystanders

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03230773
• Other study ID #: 26783
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Death
• Death, Sudden
• Death, Sudden, Cardiac
• Heart Arrest
• Sudden Death, Cardiac

Intervention

Device:
• Defibrillator model
Comparison of the performance of different public access defibrillators

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.