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ACTIVE NOT RECRUITING
NCT07905482
NA

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

Fixed PEEP Valve

8 cm H2O

DEVICE

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