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The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Sponsor: Jeroen van Eijk
Summary
The goal of this clinical trial is to learn if applying positive end-expiratory pressure (PEEP) during cardiopulmonary resuscitation (CPR) improves neurological outcome in adults with out-of-hospital cardiac arrest who receive an advanced airway (supraglottic airway device or endotracheal tube). The main question it aims to answer is: Does ventilating with 8 cm H2O PEEP during CPR improve neurological outcome at hospital discharge, as measured by the utility-weighted modified Rankin Scale (UW-mRS)? Researchers will compare an 8 cm H2O PEEP valve to a look-alike sham valve that provides no PEEP (zero end-expiratory pressure) to see if PEEP improves neurological outcome. Participants will: * Be ventilated during CPR with a resuscitator fitted with either the PEEP valve or the sham valve, assigned at random through pre-assembled kits. Patients, ambulance staff and researchers will not know which valve is used. * Receive otherwise standard advanced life support * Be asked for consent afterwards (deferred consent), with outcome data taken from routine hospital records * Complete a quality-of-life questionnaire by telephone 6 months after the arrest, if they survive
Official title: The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients suffering an Out-of-hospital Cardiac Arrest - an Investigator-initiated, Pragmatic, Registry-based, Multicenter, Parallel-group, Triple-blind Randomized Controlled Superiority Clinical Trial in the ARREST Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3200
Start Date
2026-10-05
Completion Date
2029-09-05
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Fixed PEEP Valve
8 cm H2O
Sham Valve
0 cm H2O of PEEP
Locations (3)
RAV Noord-Holland Noord
Alkmaar, Netherlands
Ambulance Amsterdam
Amsterdam, Netherlands
RAV Flevoland, Gooi- en Vechtstreek
Hilversum, Netherlands