NCT06836830

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jun 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Jun 2025Oct 2026

First Submitted

Initial submission to the registry

January 21, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

January 21, 2025

Last Update Submit

August 5, 2025

Conditions

Ventilation TherapyPEEP, OccultCPRCardiac Arrest (CA)

Keywords

Cardiac ArrestPositive End-Expiratory PressureZero End-Expiratory PressureVentilationRandomized Controlled TrialEmergency MedicineResuscitationCPR

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Re-Arrest-Rate

    Upon hospital admission

  • Death during pre-hospital care phase

    Upon hospital admission

  • Hospital admission during ongoing resuscitation

    at hospital admission

  • Hospital admission with spontaneous circulation

    at hospital admission

  • SpO2 at hospital admission

    at hospital admission

  • +1 more secondary outcomes

Study Arms (2)

PEEP

EXPERIMENTAL

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

Procedure: PEEP 5 mbar

ZEEP

EXPERIMENTAL

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

Procedure: ZEEP 0 mbar

Interventions

PEEP 5 mbarPROCEDURE

Positiv-End-Expiratory Pressure

PEEP
ZEEP 0 mbarPROCEDURE

Zero-End-Expiratory Pressure

ZEEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Emergency Medical Services

Gütersloh, North Rhine-Westphalia, 33324, Germany

RECRUITING

JWK Minden

Minden, North Rhine-Westphalia, 32429, Germany

RECRUITING

Emergency Medical Services

Osnabrück, Germany

RECRUITING

Related Publications (1)

  • Vaseekaran M, Vollmer T, Kolaparambil Varghese LJ, Zeichen C, Hinkelbein J, Abels R, Strickmann B, Deicke M, Grannemann JJ, Grunzig R, Hoyer A, Persson J, Tiesmeier J, Veit G, Jansen G. Peri-arrest ventilation with positive end-expiratory-pressure vs. zero end-expiratory-pressure in out-of-hospital-cardiac-arrest (PerAVent)-a prospective, cluster-randomized multicenter trial. Trials. 2026 Jan 21;27(1):69. doi: 10.1186/s13063-025-09292-w.

    PMID: 41566395DERIVED

MeSH Terms

Conditions

Positive-Pressure Respiration, IntrinsicHeart ArrestRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Gerrit Jansen, PD Dr. med.

CONTACT

+49 571-790-54401gerrit.jansen@muehlenkreiskliniken.de

Jochen Hinkelbein, Prof. Dr. med.

CONTACT

+49 571-790-54401jochen.hinkelbein@muehlenkreiskliniken.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2025

First Posted

February 20, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations

DE(3)