RecruitingNAINTERVENTIONAL

Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

This study, named 'Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2', is examining a new way to help people who have had a sudden cardiac arrest (when the heart stops beating) outside of hospital. Currently, after a cardiac arrest, doctors try to keep a person's body temperature normal. This study is testing if starting cooling very early, even before reaching the hospital, using a special device through the nose, can improve survival rates and help people recover with full brain function. Patients aged 18 to 79 who have had a specific type of cardiac arrest will be included. Half will receive this early cooling, and half will receive standard care, to compare the results after 90 days.

At a glance

Status

Recruiting

Phase

Sponsor

Karolinska Institutet

Enrolment target

1,022

Start

27 Mar 2024

Estimated completion

01 May 2028

Out-Of-Hospital Cardiac Arrest Hypothermia Ventricular Fibrillation

What is this study about?

When someone has a sudden cardiac arrest – meaning their heart unexpectedly stops beating – it's a very serious emergency. Even if their heart is restarted, there can be damage to the brain and other organs because they didn't get enough oxygen. Doctors are always looking for ways to improve recovery for these patients.

Currently, after a cardiac arrest, the standard treatment often involves trying to keep a person's body temperature at a normal level. However, some past research has suggested that carefully cooling the body might help protect the brain and improve outcomes. This study is taking that idea further by looking at starting the cooling process even earlier – right after paramedics arrive at the scene of the cardiac arrest.

In this study, called 'Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2', researchers want to see if this very early cooling, delivered through a special device placed in the nose, can make a difference. The main goal is to find out if this early cooling, followed by continuing cooling at the hospital, helps more people survive and recover with their brain function fully intact 90 days after their cardiac arrest, compared to the current standard approach of keeping the body temperature normal.

Key takeaways

This study is about people who have had a sudden heart stoppage outside of hospital.
It tests if starting body cooling very early (by paramedics) can help improve recovery.
The cooling is done using a special device placed in the nose.
Researchers will compare survival and brain recovery for those who get early cooling versus standard care.
Patients aged 18-79 with a specific type of cardiac arrest are included.
The aim is to find better ways to help people after cardiac arrest.

Who may be eligible?

This study is looking for adults aged between 18 and 79 years old. To be considered, you must have experienced a sudden cardiac arrest outside of a hospital, and the initial rhythm that paramedics saw on the heart monitor must have been a 'shockable rhythm' (meaning a defibrillator could be used). You also need to have been unconscious, and the cooling treatment must have been able to start within 20 minutes of the paramedics arriving.

There are some reasons why someone would not be able to join the study. These include if they are 80 years old or older, if their cardiac arrest was clearly caused by something other than a heart problem, or if they were already very cold when paramedics arrived. People with known 'Do Not Attempt Resuscitation' (DNAR) orders, a terminal illness, or who are pregnant would also not be eligible. Also, if there's a clear reason why the cooling device couldn't be placed in the nose, they wouldn't be able to take part.

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 between 18 and 79 years old?
Did you experience a sudden cardiac arrest outside of a hospital?
Was your initial heart rhythm 'shockable' (could be treated with a defibrillator)?
Were you unconscious after the cardiac arrest?
Was treatment able to start quickly after paramedics arrived?
Do you have a 'Do Not Attempt Resuscitation' (DNAR) order or other limitations on care?

Answer every question to see your result.

What does participation involve?

If suitable for the study, participants will be randomly assigned to one of two groups. This is like flipping a coin to decide, making sure the groups are as fair as possible. One group will receive the early cooling treatment where paramedics start cooling using a device through the nose at the scene of the cardiac arrest. This cooling will then continue for 24 hours once they arrive at the hospital. The other group will receive the standard care, which includes advanced life support from paramedics and keeping their body temperature at a normal level while in hospital. After the initial treatment, researchers will check on participants' survival and brain recovery 90 days later.

Potential risks and benefits

The potential benefit of participating in this study is contributing to research that could improve care for future patients who suffer a cardiac arrest. For participants in the cooling group, there's a chance the early cooling might improve their chances of survival and brain recovery, although this is what the study aims to find out. As with any medical intervention, there could be risks associated with either the cooling device or other aspects of care, though these would be carefully monitored by medical staff. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

University Hospital Vienna
Verified postcode
Vienna, Austria· Not yet recruiting
CHU Saint-Pierre
Verified postcode
Brussels, Belgium· Recruiting
Erasme University Hospital
Verified postcode
Brussels, Belgium· Recruiting
Europe Hospitals St Elizabeth
Verified postcode
Brussels, Belgium· Recruiting
University Hospital Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Verified postcode
Milan, Italy· Not yet recruiting
Ljubljana University Medical Centre
Verified postcode
Ljubljana, Slovenia· Recruiting
Hospital Universitario La Paz
Verified postcode
Madrid, Spain· Recruiting
San Carlos Clinical Hospital
Verified postcode
Madrid, Spain· Recruiting
Karolinska University Hospital
Verified postcode
Stockholm, Sweden· Recruiting
Södersjukhuset
Verified postcode
Stockholm, Sweden· Recruiting

Common questions

What is 'cardiac arrest'?

Cardiac arrest means your heart has suddenly stopped beating, leading to a loss of blood flow to the brain and other organs. It's different from a heart attack.

What is 'cooling' in this study?

Cooling means carefully lowering the body's temperature. In this study, it's done very early through a special device placed in the nose, aiming to protect the brain.

What does a 'shockable rhythm' mean?

This refers to a specific type of abnormal heart rhythm that can sometimes be corrected by an electric shock from a defibrillator, which paramedics can use.

Will I know if I'm in the cooling group?

Because this is an emergency situation, the decision about which group a patient is in would be made rapidly by the medical team. However, the study will compare outcomes between the groups.

What is 'normothermia'?

Normothermia simply means maintaining a normal body temperature, which is the current standard approach after cardiac arrest in many situations.

How to find out more

Per Nordberg, MD, PhD

per.nordberg@ki.se +46702802579 Official trial record

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