RecruitingPHASE3INTERVENTIONAL

The Application of Positive End-Expiratory Pressure in Out-of-Hospital Cardiac Arrest: The Lazarus-PEEP Trial.

This study, called Lazarus-PEEP, investigates whether adding a special breathing technique called Positive End-Expiratory Pressure (PEEP) to CPR improves outcomes for adults who have a sudden cardiac arrest outside of a hospital. When someone's heart stops, CPR helps, but keeping airways open properly is key. PEEP is a way to make sure the airways stay open, potentially boosting oxygen levels. Researchers want to see if using PEEP helps restart the heart more effectively, leads to more people surviving, and helps survivors recover with good brain function, compared to standard CPR. They will divide participants into two groups: one receiving CPR with PEEP and one with standard CPR.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Ghent

Enrolment target

132

Start

25 Apr 2025

Estimated completion

01 Feb 2027

Cardiac Arrest (CA)Out-of-hospital Cardiac Arrest (OHCA)Positive End-expiratory Pressure (PEEP)Ventilation During Resuscitation

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. When this happens, paramedics and emergency medical teams perform CPR (cardiopulmonary resuscitation) to try and restart the heart and keep blood flowing. Part of CPR involves helping the person breathe, which is called ventilation.

This study is looking at a specific way to help with breathing during CPR called Positive End-Expiratory Pressure, or PEEP. Think of it like a little bit of continuous gentle pressure kept in the lungs at the end of each breath. The idea behind PEEP is that it might help keep the tiny air sacs in the lungs open, which could help more oxygen get into the body. This study wants to find out if using PEEP during CPR can make a real difference in helping people survive and recover well after a cardiac arrest.

Researchers will compare two groups of patients: one group will receive standard CPR, and the other will receive CPR that includes PEEP. They'll be checking to see if PEEP helps restart the heart more often, if more people survive to leave the hospital, and if those who survive have better brain function. The findings from this study could change how emergency teams provide CPR in the future, aiming to give patients the very best chance of recovery.

Key takeaways

This study evaluates PEEP during CPR for out-of-hospital cardiac arrest.
PEEP is a breathing technique that may help keep airways open.
It aims to see if PEEP improves survival and recovery compared to standard CPR.
Participants are randomly assigned to either receive PEEP or standard CPR.
The study findings could influence future CPR guidelines.
Safety is being monitored, including potential side effects like lung pressure.

Who may be eligible?

This study is looking for adults aged 18 or older who have had a sudden cardiac arrest outside of a hospital. The cardiac arrest must not have been caused by an accident or injury, like a car crash or drowning.

To be included, patients must be receiving CPR from an advanced medical team and need to have a breathing tube inserted and be helped to breathe by a machine or device during the resuscitation efforts. If someone achieves a normal heartbeat before they can be intubated, or if the breathing tube cannot be inserted successfully, they cannot be part of the study.

There are also some reasons why someone could not take part. These include being under 18, being pregnant, already having specific medical instructions not to be resuscitated (a 'Do Not Resuscitate' order), or already being on a breathing machine for another reason when the cardiac arrest happened. Also, if someone is already in another medical study that might affect the results of this one, they won't be able to join this study.

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?
Did your heart stop outside of a hospital, not due to an injury?
Are you receiving CPR from an advanced medical team?
Do you need a breathing tube for ventilation during CPR?
Are you not pregnant?
Do you not have an existing 'Do Not Resuscitate' order?

Answer every question to see your result.

What does participation involve?

If someone is eligible for this study, they will be randomly assigned to one of two groups: either they will receive standard CPR, or they will receive CPR with the PEEP technique added. This decision is made by chance, like flipping a coin. Specialist emergency medical teams, who are highly trained, will carry out the resuscitation. During this time, special sensors will be used to measure airflow and pressure in the breathing tubes. The study primarily focuses on the events during the initial resuscitation in an emergency. There isn't an ongoing visit schedule or long-term follow-up specifically for study participation beyond observing how the patient recovers and assessing their health outcomes at discharge from the hospital.

Potential risks and benefits

The main benefit potentially explored by this trial is that using PEEP during CPR might improve a patient's chances of survival and recovery with good health. However, as with any medical procedure, there are potential small risks. PEEP involves keeping a bit of pressure in the lungs, which could, in rare cases, lead to increased pressure in the chest or potentially injure the lungs. The research team will carefully monitor for any such side effects. Patients (or their legal representatives, if they are unable to decide for themselves) always have the right to withdraw from the study at any time without it affecting their medical care.

Locations (7)

AZ Oostende
Verified postcode
Ostend, Belgium· Recruiting
AZORG: campus Merestraat
Verified postcode
Aalst, Belgium· Recruiting
AZORG: Campus Moorselbaan
Verified postcode
Aalst, Belgium· Recruiting
AZORG: campus Geraardsbergen
Verified postcode
Geraardsbergen, Belgium· Recruiting
UZ Ghent
Verified postcode
Ghent, Belgium· Recruiting
AZ Zeno
Verified postcode
Knokke, Belgium· Recruiting
Centre hospitalier universitaire (CHU) Besançon-Franche-Comté
Verified postcode
Besançon, France· Active not recruiting

Common questions

What is 'cardiac arrest'?

Cardiac arrest is when your heart suddenly stops beating, and blood stops flowing to your brain and other organs. It's a medical emergency.

What is PEEP?

PEEP stands for Positive End-Expiratory Pressure. It's a technique used during breathing support to help keep the small air sacs in your lungs open.

Will I know if I'm in the PEEP group or the standard CPR group?

Patients are randomly assigned to a group, like drawing lots. In an emergency, you may not be aware of which group you're in at the time of treatment.

Who is carrying out this study?

This study is being conducted by emergency medical teams and researchers at Ghent University Hospital and other hospitals in Belgium.

What happens after the study?

The information gathered will help doctors understand if PEEP should be used more widely during CPR to improve patient outcomes.

How to find out more

Thomas Tackaert, MD

thomas.tackaert@ugent.be 0032 53 72 49 96 Official trial record

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