Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06939335

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

Led by University Hospital, Ghent · Updated on 2026-01-21

132

Participants Needed

7

Research Sites

35 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial focuses on adults who experience out-of-hospital cardiac arrest, where the heart suddenly stops beating. Researchers are studying whether using Positive End-Expiratory Pressure (PEEP) during cardiopulmonary resuscitation (CPR) improves outcomes such as restarting the heart, survival rates, and neurological function compared to standard CPR without PEEP. This study is a phase 3 randomized trial addressing a gap in knowledge about ventilation during CPR and its impact on patient outcomes. Participants are randomly assigned to one of two groups: one receives CPR with PEEP set at 5 cm H2O using an adult resuscitation bag with a disposable PEEP valve, and the other receives standard CPR without PEEP using the same type of resuscitation bag but without the PEEP valve. Ventilation and airway pressures are monitored with specialized sensors during resuscitation by advanced life support medical teams. The study evaluates both effectiveness and safety, including potential side effects like increased chest pressure or lung injury. During the study, participants' return of spontaneous circulation (ROSC) is measured as the primary outcome. Secondary outcomes include survival to hospital admission and discharge, 30- and 90-day survival, and neurological function at discharge. Data on CPR quality and physiological measurements are collected. The trial follows participants from enrollment through hospital discharge or death, with detailed monitoring of outcomes and safety to guide future CPR guidelines.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • Experienced a non-traumatic out-of-hospital cardiac arrest
  • Receiving cardiopulmonary resuscitation from an advanced life support team
  • Intubated and ventilated during resuscitation efforts
Not Eligible

You will not qualify if you...

  • Cardiac arrest in patients younger than 18 years
  • Traumatic cardiac arrest including drowning, penetrating or blunt injury, and burns
  • Immediate return of spontaneous circulation before intubation
  • Pregnancy
  • Already receiving mechanical ventilation at the time of cardiac arrest for other reasons
  • Existing do not resuscitate (DNR) orders or advanced directives against CPR
  • Failure to intubate
  • Currently enrolled in another interventional clinical trial that could interfere with this study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Treatment

Duration - Until return of spontaneous circulation or end of resuscitation efforts

Participants receive ventilation during cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest using either a resuscitation bag with a disposable PEEP valve set at 5 cm H2O or a resuscitation bag without a PEEP valve.

1 treatment event during resuscitation

Follow-up

Duration - Up to 90 days after enrollment

Participants are monitored for survival and neurological outcomes up to 90 days after enrollment.

Follow-up assessments at hospital admission, discharge, 30 days, and 90 days

Trial Site Locations

Total: 7 locations

1

AZ Oostende

Ostend, West-Flandres, Belgium, 8400

Actively Recruiting

2

AZORG: campus Merestraat

Aalst, Belgium, B-9300

Actively Recruiting

3

AZORG: Campus Moorselbaan

Aalst, Belgium, B-9300

Actively Recruiting

4

AZORG: campus Geraardsbergen

Geraardsbergen, Belgium, B-9500

Actively Recruiting

5

UZ Ghent

Ghent, Belgium, B-9240

Actively Recruiting

6

AZ Zeno

Knokke, Belgium, 8300

Actively Recruiting

7

Centre hospitalier universitaire (CHU) Besançon-Franche-Comté

Besançon, France

Active, Not Recruiting

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Research Team

T

Thomas Tackaert, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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