RecruitingNAINTERVENTIONAL

Cardiac Arrest Bundle of cARE Trial

This study, called the 'Cardiac Arrest Bundle of cARE Trial,' is investigating a new way to help people who experience a sudden heart stop, known as a cardiac arrest, outside of a hospital. When someone has a cardiac arrest, their heart stops beating, and their body's vital organs don't get enough blood. This study focuses on using a special combination of three medical devices during CPR (Cardiopulmonary Resuscitation) to try and improve blood flow, especially to the brain and heart. Researchers hope this 'bundle of care' could lead to more people surviving cardiac arrests and recovering without brain damage. This initial stage is a pilot study to find out if using these devices together is practical and effective, which will help them plan a larger study in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

Start

24 May 2024

Estimated completion

30 Aug 2025

Cardiopulmonary Resuscitation Cardiac Arrest Out of Hospital Cardiac Arrest

What is this study about?

Imagine someone's heart suddenly stops beating outside of a hospital – this is called an out-of-hospital cardiac arrest. It's a very serious emergency because when the heart stops, blood doesn't flow to the rest of the body, especially the brain. If this goes on for too long, it can unfortunately be fatal or cause severe damage. In the UK, this happens to many people every year, often at home, and even with quick help from paramedics, survival rates can be quite low.

This study is looking at a new approach to help improve the chances of survival after an out-of-hospital cardiac arrest. Doctors are testing a 'bundle' of three special devices that are used together during CPR. These devices are designed to work in combination to improve how well blood flows around the body, particularly to the brain and heart, during resuscitation efforts. The idea is that better blood flow could help restart the heart more effectively and protect the brain from damage, leading to more people surviving and recovering well.

This first step is a small study to see if using these three devices together is practical and safe for paramedics to use in real-life emergency situations. The information gathered from this pilot study will be really important. It will help the research team understand if this new approach is promising enough to move forward with a much bigger study. If the results are good, a larger study could then definitively show if this technology can make a real difference in saving lives and improving recovery for people who suffer a cardiac arrest.

Key takeaways

This study tests new technology for sudden heart stops outside hospital.
It uses three devices together during CPR to improve blood flow.
The goal is to increase survival rates and protect the brain.
It's a pilot study to see if the new approach is practical and safe.
Only adults whose cardiac arrest was witnessed within 20 minutes can take part.

Who may be eligible?

To be part of this study, patients need to be adults, meaning they are 18 years old or older. The medical team also needs to be sure that the patient's body shape and size would allow the special medical devices to be used properly.

Crucially, someone must have seen the cardiac arrest happen, and the medical team needs to know that it happened within the last 20 minutes before they arrived. This helps ensure the devices are used when they are most likely to be helpful.

Some people, however, would not be able to join the study. This includes pregnant women, prisoners, or if the heart stop was caused by a serious injury like a car accident, drowning, or hanging. Also, if a patient has a 'Do Not Attempt Cardiopulmonary Resuscitation' (DNACPR) order, or if the cardiac arrest is known to have happened for 21 minutes or longer, they cannot be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Was your heart stop witnessed by someone?
Did your heart stop less than 20 minutes ago (to the best of knowledge)?
Is your body shape generally suitable for medical devices?

Answer every question to see your result.

What does participation involve?

This study involves paramedics attempting to use three special devices during emergency CPR for people who have had a sudden heart stop outside of hospital. If a patient is chosen for the study, they would receive CPR with these devices as part of their emergency care. There aren't any extra clinic visits, blood tests, or follow-up appointments directly related to the study itself for the patient. The medical team will collect information about the patient's condition and survival from their standard hospital records. The total duration of participation for an individual depends on their medical outcome after the cardiac arrest, but the study is about what happens during the emergency resuscitation.

Potential risks and benefits

The potential benefit of taking part is that the use of these new devices might improve blood flow during CPR, which could increase the chances of survival and better recovery. However, like all medical interventions, there could be risks, although the devices are designed to improve existing CPR and are used by trained paramedics. For example, there's always a chance of complications with any medical equipment used during an emergency. It's important to remember that participation is entirely voluntary. Patients, or their families in an emergency situation, always have the right to withdraw from the study at any time without affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Southampton NHS Foundation trust
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is a 'cardiac arrest'?

A cardiac arrest means your heart suddenly stops beating, and you become unconscious. It's a very serious medical emergency.

What are these 'devices'?

These are special tools used during CPR to try and improve blood flow to the brain and heart. They include a head-up device, a mechanical chest compression device, and one that helps regulate breathing.

Who is eligible for this study?

Adults over 18 who have had a cardiac arrest witnessed by someone, and where it happened less than 20 minutes ago. There are specific reasons why some people can't join.

Will I have extra appointments if I'm in the study?

No, there are no extra appointments related to this study. The information is collected from standard medical records.

What happens if someone doesn't want to be in the study?

Participation is voluntary. Even if someone is included, their family can say they don't want them in the study, and it won't affect their medical treatment.

How to find out more

James OM Plumb, PhD

j.plumb@soton.ac.uk 07967319438 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.