PEEP vs. ZEEP in Out-of-Hospital-Cardiac-Arrest

NCT ID: NCT06836830

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-10-31

Brief Summary

Out-of-hospital cardiac arrest (OHCA) remains a major cause of mortality, with low survival probabilities to hospital discharge. Despite the frequent use of airway management and mechanical ventilation during resuscitation, there is limited evidence regarding the optimal ventilation strategy to improve oxygen delivery and patient outcomes. The present study aims to investigate the effects of positive-end-expiratory-pressure (PEEP) set at 5 mbar compared to zero-end-expiratory-pressure (ZEEP) on the return of spontaneous-circulation (ROSC) in adult patients with OHCA.

Detailed Description

This is a prospective, multicenter, cluster-randomized controlled trial conducted across emergency medical services (EMS) in the regions of Guetersloh, Minden-Luebbecke and Osnabrueck. Adult patients (>= 18 years) with OHCA who are undergoing mechanical ventilation through an airway device will be enrolled. The clusters (regional district) will be randomized into two groups: one group will receive ventilation with PEEP set at 5 mbar (intervention group), while the other group will receive ventilation with ZEEP (control group). The study's primary endpoint is the rate of ROSC. Secondary endpoints include rate of re-arrest, death during pre-hospital care phase, hospital admission during ongoing resuscitation, hospital admission with spontaneous circulation, peripheral oxygen saturation and end tidal CO2 at hospital admission.

Conditions

Ventilation Therapy; PEEP, Occult; CPR; Cardiac Arrest (CA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

PEEP

PEEP Group (Intervention Group): Patients will receive mechanical ventilation with end-expiratory-pressure set at 5 mbar (PEEP).

Group Type: EXPERIMENTAL

PEEP 5 mbar

Intervention Type: PROCEDURE

Positiv-End-Expiratory Pressure

ZEEP

ZEEP Group (Control Group): Patients will receive mechanical ventilation with end-expiratory-pressure set at 0 mbar (ZEEP).

Group Type: EXPERIMENTAL

ZEEP 0 mbar

Intervention Type: PROCEDURE

Zero-End-Expiratory Pressure

Interventions

PEEP 5 mbar

Positiv-End-Expiratory Pressure

Intervention Type: PROCEDURE

ZEEP 0 mbar

Zero-End-Expiratory Pressure

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adults >= 18 years
• non-traumatic OHCA
• mechanical ventilation via airway device

Exclusion Criteria

• Patients < 18 years,
• traumatic cause of OHCA,
• no cardiac arrest, withholding of resuscitation (e.g. Do-Not-Resuscitate orders)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muehlenkreiskliniken, MKK

OTHER

Sponsor Role: lead

Responsible Party

Gerrit Jansen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emergency Medical Services

Gütersloh, North Rhine-Westphalia, Germany

Site Status: RECRUITING

JWK Minden

Minden, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Emergency Medical Services

Osnabrück, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Gerrit Jansen, PD Dr. med.

Role: CONTACT

gerrit.jansen@muehlenkreiskliniken.de

+49 571-790-54401

Jochen Hinkelbein, Prof. Dr. med.

Role: CONTACT

jochen.hinkelbein@muehlenkreiskliniken.de

+49 571-790-54401

Facility Contacts

Julia Johanna Grannemann, MD, MSc

Role: primary

j.grannemann@kreis-guetersloh.de

+491706765460

Bernd Strickmann, MD

Role: backup

b.strickmann@kreis-guetersloh.de

Jochen Hinkelbein, MD

Role: primary

Other Identifiers

2024-1148

Identifier Type: -

Identifier Source: org_study_id