PEEP vs. ZEEP in Out-of-Hospital-Cardiac-Arrest (PerAVent)

Peri-Arrest Ventilation With Positive End-Expiratory-Pressure vs. Zero End-Expiratory-Pressure in Out-of-Hospital-Cardiac-Arrest

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest (CA); PEEP, Occult; CPR; Ventilation Therapy
• Intervention / Treatment: Procedure: PEEP 5 mbar; Procedure: ZEEP 0 mbar

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerrit Jansen, PD Dr. med.; Phone Number: +49 571-790-54401; Email: gerrit.jansen@muehlenkreiskliniken.de
• Study Contact Backup: Name: Jochen Hinkelbein, Prof. Dr. med.; Phone Number: +49 571-790-54401; Email: jochen.hinkelbein@muehlenkreiskliniken.de

Study Locations

• Germany
  • Osnabrück, Germany
    • Recruiting
    • Emergency Medical Services
  • NRW
    • Minden, NRW, Germany, 32429
      • Recruiting
      • JWK Minden
      • Contact: Jochen Hinkelbein, MD
  • North Rhine-Westphalia
    • Gütersloh, North Rhine-Westphalia, Germany, 33324
      • Recruiting
      • Emergency Medical Services
      • Contact: Julia Johanna Grannemann, MD, MSc; Phone Number: +491706765460; Email: j.grannemann@kreis-guetersloh.de
      • Contact: Bernd Strickmann, MD; Email: b.strickmann@kreis-guetersloh.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEEP; PEEP Group (Intervention Group): Patients will receive mechanical ventilation with end-expiratory-pressure set at 5 mbar (PEEP).	Procedure: PEEP 5 mbar; Positiv-End-Expiratory Pressure
Experimental: ZEEP; ZEEP Group (Control Group): Patients will receive mechanical ventilation with end-expiratory-pressure set at 0 mbar (ZEEP).	Procedure: ZEEP 0 mbar; Zero-End-Expiratory Pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The return of spontaneous circulation (ROSC)	The primary outcome is the ROSC, defined according to the Utstein template by the presence of a palpable pulse during or after resuscitation. This will be measured as a binary outcome (palpable pulse, yes or no).	During or after resuscitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-Arrest-Rate	Any need for chest compressions after ROSC (yes vs. no)	Upon hospital admission
Death during pre-hospital care phase	Any death during pre-hospital care phase (yes vs. no)	Upon hospital admission
Hospital admission during ongoing resuscitation	Need for chest-compressions at hospital admission (yes vs. no)	at hospital admission
Hospital admission with spontaneous circulation	Hospital admission with spontaneous circulation without need for chest compressions (yes vs. no)	at hospital admission
SpO2 at hospital admission	SpO2 at hospital admission (%)	at hospital admission
FiO2 at hospital admission	FiO2 at hospital admission (%)	at hospital admission

Collaborators and Investigators

• Sponsor: Muehlenkreiskliniken, MKK

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): February 20, 2025

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Emergency Medicine; Randomized Controlled Trial; CPR; Cardiac Arrest; Resuscitation; Ventilation; Positive End-Expiratory Pressure; Zero End-Expiratory Pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Heart Arrest; Out-of-Hospital Cardiac Arrest; Positive-Pressure Respiration, Intrinsic
• Other Study ID Numbers: 2024-1148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No