Cardiac ArrestNCT03230773
Use of Public Access Defibrillators by Untrained Bystanders
A study testing Defibrillator model in people with Cardiac Arrest and Sudden Death, Cardiac, run by University Hospital Southampton NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Sudden Death, Cardiac
- What is being tested?
- Defibrillator model
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Members of the public who have never received any first aid (CPR) training
Who cannot join
- Those less than 16 yrs age
- Those with any physical disability precluding the use of a PAD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Arrest, Sudden Death, Cardiac
- Being tested
- Defibrillator model
- Medical subject headings
- Heart Arrest, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defibrillator modelDevice
Comparison of the performance of different public access defibrillators
| Study group | Role | What they receive |
|---|---|---|
| Defibrillator - Model 1 | Experimental | Time taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Defibrillator model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Comparison of median time taken to achieve this endpoint for each type of defibrillator
Measured: 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)
Measured: Within the 5 mins of the simulated cardiac arrest.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Apr 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Why it stopped: Postponed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomised study with volunteers randomised to use one of six different defibrillator designs.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles D. Deakin, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230773
- Sponsor's protocol ID
- 26783
- Status last verified
- May 2022
- First submitted
- 23 Jul 2017
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Untrained Bystanders Safely and Effectively Use an Automated External Defibrillator (AED) in a Cardiac Arrest Scenario?
- ClinicalTrials.gov ID
- NCT03230773
- Acronym / sponsor ID
- 26783
- Conditions
- Cardiac Arrest, Sudden Death, Cardiac
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Postponed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Prospective, randomised study with volunteers randomised to use one of six different defibrillator designs.
| Arm | Type | Receives |
|---|---|---|
| Defibrillator - Model 1 | Experimental | Device: Defibrillator modelTime taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario. |
| Defibrillator - Model 2 | Experimental | Device: Defibrillator modelTime taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario. |
| Defibrillator - Model 3 | Experimental | Device: Defibrillator modelTime taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario. |
| Defibrillator - Model 4 | Experimental | Device: Defibrillator modelTime taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario. |
| Defibrillator - Model 5 | Experimental | Device: Defibrillator modelTime taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario. |
| Defibrillator - Model 6 | Experimental | Device: Defibrillator modelTime taken to open, attach and then discharge the defibrillator on a manikin during a simulated cardiac arrest scenario. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Members of the public who have never received any first aid (CPR) training
Key exclusion criteria (2 listed)
- Those less than 16 yrs age
- Those with any physical disability precluding the use of a PAD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defibrillator modelComparison of the performance of different public access defibrillators | Device | Defibrillator - Model 1, Defibrillator - Model 2, Defibrillator - Model 3, Defibrillator - Model 4, Defibrillator - Model 5, Defibrillator - Model 6 |
Primary outcome
Time from arrival at patient side to discharging a defibrillation shock
Time frame: Within the 5 mins of the simulated cardiac arrest.
Comparison of median time taken to achieve this endpoint for each type of defibrillator
2 secondary outcomes
Time from arrival at patient side to correct application of self-adhesive defibrillation pads
Time frame: Within the 5 mins of the simulated cardiac arrest.
Following of written and verbal instructions to ensure safe use of device
Time frame: Within the 5 mins of the simulated cardiac arrest.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Defibrillator model in people with Cardiac Arrest and Sudden Death, Cardiac, run by University Hospital Southampton NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from arrival at patient side to discharging a defibrillation shock (time frame: Within the 5 mins of the simulated cardiac arrest.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.