Using Positive End-Expiratory Pressure during CPR for Cardiac Arrest

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

This study is testing if using a special breathing technique during CPR can help adults who have a cardiac arrest outside of the hospital survive better and have good brain function afterwards.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Ghent (Academic / other)
• Locations: 7 sites (Ostend, West-Flandres and 6 other locations)
• Trial ID: NCT06939335 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether applying Positive End-Expiratory Pressure (PEEP) during cardiopulmonary resuscitation (CPR) can improve outcomes for adults experiencing out-of-hospital cardiac arrest. Participants will be randomly assigned to receive either CPR with PEEP set at 5 cm of water pressure or standard CPR without PEEP. The study aims to evaluate the effectiveness of PEEP in enhancing oxygenation, increasing the rate of Return of Spontaneous Circulation (ROSC), and improving survival rates with favorable neurological outcomes. The trial will be conducted in Belgium, involving emergency medical teams trained in advanced life support.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced a non-traumatic out-of-hospital cardiac arrest and are receiving CPR from an advanced life support team.

Not a fit: Patients with traumatic cardiac arrest, those who achieve spontaneous circulation before intubation, or individuals with existing Do Not Resuscitate (DNR) orders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and neurological outcomes for patients who experience out-of-hospital cardiac arrest.

How similar studies have performed: Previous observational studies have suggested potential benefits of PEEP during CPR, but this is the first prospective randomized clinical trial to confirm these findings.

Eligibility criteria

Inclusion Criteria:

1. Age: Adults aged 18 years and older.
2. Type of Cardiac Arrest: Patients who have experienced a non-traumatic out-of-hospital cardiac arrest.
3. CPR Administration: Patients receiving cardiopulmonary resuscitation from an advanced life support (ALS) team.
4. Intubation and Ventilation: Patients who are intubated and ventilated during resuscitation efforts.

Exclusion Criteria:

1. Cardiac arrest in patient younger than 18 years of age.
2. Traumatic cardiac arrest, including drowning, penetrating or blunt injury, and burns.
3. Immediate Return of Spontaneous Circulation (ROSC): Patients who achieve ROSC before intubation and initiation of intubation.
4. Pregnancy.
5. Mechanical ventilation during arrest: patients already receiving mechanical ventilation at the moment of cardiac arrest, due to reasons other than their arrest, will be excluded.
6. Do Not Resuscitate (DNR) Orders: Patients with existing DNR orders or any advanced directive indicating that CPR should not be performed.
7. Failure to intubate: if intubation is unsuccessful, ventilation by any means (MBV, SGA) should take priority over the study protocol, and the patient is excluded.
8. Enrolment in Other Studies: Patients currently enrolled in another interventional clinical trial that could interfere with the outcomes of this study.

Where this trial is running

Ostend, West-Flandres and 6 other locations

• AZ Oostende — Ostend, West-Flandres, Belgium (Recruiting)
• AZORG: campus Merestraat — Aalst, Belgium (Recruiting)
• AZORG: Campus Moorselbaan — Aalst, Belgium (Recruiting)
• AZORG: campus Geraardsbergen — Geraardsbergen, Belgium (Recruiting)
• UZ Ghent — Ghent, Belgium (Recruiting)
• AZ Zeno — Knokke, Belgium (Recruiting)
• Centre hospitalier universitaire (CHU) Besançon-Franche-Comté — Besançon, France (Active_not_recruiting)

Study contacts

• Principal investigator: Saïd Hachimi Idrissi, MD, PhD, Professor — UZ Gent
• Study coordinator: Thomas Tackaert, MD

Conditions Cardiac Arrest; Out-of-hospital Cardiac Arrest; Positive End-expiratory Pressure; Ventilation During Resuscitation