Use of Public Access Defibrillators by Untrained Bystanders

NCT03230773 | Withdrawn

• 1 other identifier: 26783
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Arrest; Sudden Death, Cardiac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time from arrival at patient side to correct application of self-adhesive defibrillation pads

  Within the 5 mins of the simulated cardiac arrest.

• Following of written and verbal instructions to ensure safe use of device

  Within the 5 mins of the simulated cardiac arrest.

Study Arms (6)

Defibrillator - Model 1

EXPERIMENTAL

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

Device: Defibrillator model

Defibrillator - Model 2

EXPERIMENTAL

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

Device: Defibrillator model

Defibrillator - Model 3

EXPERIMENTAL

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

Device: Defibrillator model

Defibrillator - Model 4

EXPERIMENTAL

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

Device: Defibrillator model

Defibrillator - Model 5

EXPERIMENTAL

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

Device: Defibrillator model

Defibrillator - Model 6

EXPERIMENTAL

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

Device: Defibrillator model

Interventions

Defibrillator model DEVICE

Comparison of the performance of different public access defibrillators

Defibrillator - Model 1; Defibrillator - Model 2; Defibrillator - Model 3; Defibrillator - Model 4; Defibrillator - Model 5; Defibrillator - Model 6

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

MeSH Terms

Conditions

Heart Arrest; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Resuscitation

Model Details: Prospective, randomised study with volunteers randomised to use one of six different defibrillator designs.

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: July 26, 2017
• Study Start: April 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05