RecruitingPhase 3NCT06939335

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

Sponsor

University Hospital, Ghent

Enrollment

132 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiac Arrest (CA)

Summary

The goal of this clinical trial is to learn whether using Positive End-Expiratory Pressure (PEEP) during cardiopulmonary resuscitation (CPR) improves outcomes for adults who experience out-of-hospital cardiac arrest, a condition where the heart suddenly stops beating. PEEP is used during ventilation, which may enhance oxygen levels by keeping the airways open throughout CPR. This study aims to determine if using PEEP during CPR helps restart the heart more effectively, improves survival rates, and enhances survival with good neurologic outcomes after a cardiac arrest compared to standard CPR without PEEP. Researchers will randomly assign participants to one of two groups: one receiving CPR with PEEP set at 5 cm of water pressure and the other receiving standard CPR without PEEP. Participants will be treated by emergency medical teams trained in advanced life support, and specialised sensors will measure airflow and airway pressure during resuscitation. Additionally, the study will evaluate potential side effects associated with PEEP, such as increased pressure within the chest or lung injuries. Findings from this trial will guide recommendations on the usage of PEEP in standard CPR practices to potentially improve patient outcomes.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria8

Cardiac arrest in patient younger than 18 years of age.
Traumatic cardiac arrest, including drowning, penetrating or blunt injury, and burns.
Immediate Return of Spontaneous Circulation (ROSC): Patients who achieve ROSC before intubation and initiation of intubation.
Pregnancy.
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.
Do Not Resuscitate (DNR) Orders: Patients with existing DNR orders or any advanced directive indicating that CPR should not be performed.
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.
Enrolment in Other Studies: Patients currently enrolled in another interventional clinical trial that could interfere with the outcomes of this study.

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Interventions

DEVICEDisposable PEEP Valve set at 5 cm H20.

Ventilation during cardiac arrest with an adult Resuscitation Bag with a pressure relief valve set at 40 cm H20 and a 22 mm disposable PEEP Valve set at 5 cm H20.

DEVICEControle

Ventilation during cardiac arrest with an adult Resuscitation Bag with a pressure relief valve set at 40 cm H20 without a disposable PEEP Valve.