NCT06939335

Brief Summary

The goal of this clinical trial is to learn whether using Positive End-Expiratory Pressure (PEEP) during cardiopulmonary resuscitation (CPR) improves outcomes for adults who experience out-of-hospital cardiac arrest, a condition where the heart suddenly stops beating. PEEP is used during ventilation, which may enhance oxygen levels by keeping the airways open throughout CPR. This study aims to determine if using PEEP during CPR helps restart the heart more effectively, improves survival rates, and enhances survival with good neurologic outcomes after a cardiac arrest compared to standard CPR without PEEP. Researchers will randomly assign participants to one of two groups: one receiving CPR with PEEP set at 5 cm of water pressure and the other receiving standard CPR without PEEP. Participants will be treated by emergency medical teams trained in advanced life support, and specialised sensors will measure airflow and airway pressure during resuscitation. Additionally, the study will evaluate potential side effects associated with PEEP, such as increased pressure within the chest or lung injuries. Findings from this trial will guide recommendations on the usage of PEEP in standard CPR practices to potentially improve patient outcomes.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
9mo left

Started Apr 2025

Geographic Reach
2 countries

7 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 Progress58%
Apr 2025Feb 2027

First Submitted

Initial submission to the registry

March 31, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

April 25, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

March 31, 2025

Last Update Submit

January 20, 2026

Conditions

Cardiac Arrest (CA)Out-of-hospital Cardiac Arrest (OHCA)Positive End-expiratory Pressure (PEEP)Ventilation During Resuscitation

Outcome Measures

Primary Outcomes (1)

  • Return of spontaneous circulation (ROSC)

    The occurrence of Return of spontaneous circulation (ROSC), defined as the return of sustained spontaneous circulation for at least 20 minutes per ERC guidelines

    Day one

Secondary Outcomes (5)

  • Survival to hospital admission

    Day one

  • Survival to hospital discharge

    From enrolment until hospital discharge or death - whichever happens first. Average hospitalisation after OHCA is 24 days.

  • 30-day survival

    From enrollment to the end of 30 days.

  • 90-day survival

    From enrollment to the end of 90 days.

  • Neurological outcome at discharge

    From enrolment until hospital discharge or death - whichever happens first. Average hospitalisation after OHCA is 24 days.

Other Outcomes (6)

  • Airflow during ventilation

    Periprocedural

  • Airway pressure during ventilation

    Periprocedural

  • Occurence of potential adverse effects

    Day one

  • +3 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Ventilation during cardiac arrest with an adult Resuscitation Bag with a pressure relief valve set at 40 cm H20 and a disposable PEEP Valve set at 5 cm H20.

Device: Disposable PEEP Valve set at 5 cm H20.

Controle

ACTIVE COMPARATOR

Ventilation during cardiac arrest with an adult Resuscitation Bag with a pressure relief valve set at 40 cm H20 without a disposable PEEP Valve.

Device: Controle

Interventions

Disposable PEEP Valve set at 5 cm H20.DEVICE

Ventilation during cardiac arrest with an adult Resuscitation Bag with a pressure relief valve set at 40 cm H20 and a 22 mm disposable PEEP Valve set at 5 cm H20.

Intervention
ControleDEVICE

Ventilation during cardiac arrest with an adult Resuscitation Bag with a pressure relief valve set at 40 cm H20 without a disposable PEEP Valve.

Controle

Eligibility Criteria

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

You may qualify if:

  • Age: Adults aged 18 years and older.
  • Type of Cardiac Arrest: Patients who have experienced a non-traumatic out-of-hospital cardiac arrest.
  • CPR Administration: Patients receiving cardiopulmonary resuscitation from an advanced life support (ALS) team.
  • Intubation and Ventilation: Patients who are intubated and ventilated during resuscitation efforts.

You may not qualify if:

  • Cardiac arrest in patient younger than 18 years of age.
  • Traumatic cardiac arrest, including drowning, penetrating or blunt injury, and burns.
  • Immediate Return of Spontaneous Circulation (ROSC): Patients who achieve ROSC before intubation and initiation of intubation.
  • Pregnancy.
  • Mechanical ventilation during arrest: patients already receiving mechanical ventilation at the moment of cardiac arrest, due to reasons other than their arrest, will be excluded.
  • Do Not Resuscitate (DNR) Orders: Patients with existing DNR orders or any advanced directive indicating that CPR should not be performed.
  • Failure to intubate: if intubation is unsuccessful, ventilation by any means (MBV, SGA) should take priority over the study protocol, and the patient is excluded.
  • Enrolment in Other Studies: Patients currently enrolled in another interventional clinical trial that could interfere with the outcomes of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

AZ Oostende

Ostend, West-Flandres, 8400, Belgium

RECRUITING

AZORG: campus Merestraat

Aalst, B-9300, Belgium

RECRUITING

AZORG: Campus Moorselbaan

Aalst, B-9300, Belgium

RECRUITING

AZORG: campus Geraardsbergen

Geraardsbergen, B-9500, Belgium

RECRUITING

UZ Ghent

Ghent, B-9240, Belgium

RECRUITING

AZ Zeno

Knokke, 8300, Belgium

RECRUITING

Centre hospitalier universitaire (CHU) Besançon-Franche-Comté

Besançon, France

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Saïd Hachimi Idrissi, MD, PhD, Professor

    UZ Gent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Tackaert, MD

CONTACT

0032 53 72 49 96thomas.tackaert@ugent.be

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter parallel controlled randomised clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 22, 2025

Study Start

April 25, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

FR(1)BE(6)