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Active, not recruitingNCT07905482REVIVE-PEEPUpdated Oct 29, 2026

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 interventional study of Fixed PEEP Valve and Sham Valve in Cardiac Arrest, Out-Of-Hospital, sponsored by Jeroen van Eijk. Active, not recruiting at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Jeroen van Eijk · Not applicable, Interventional, and Treatment

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
3,200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
Read the detailed description

Rationale Cardiopulmonary resuscitation (CPR) aims to provide oxygen to vital organs through chest compressions and ventilations, until return of spontaneous circulation (ROSC) is achieved. A major barrier to effective oxygenation during CPR is atelectasis, which impairs gas exchange and results in hypoxemia-a condition strongly associated with decreased rates of ROSC and worsened neurological outcomes.

Positive end-expiratory pressure (PEEP) is routinely used in critical care to prevent atelectasis and improve oxygenation. During CPR, however, its use is inconsistent and subject of debate. This reflects long-standing theoretical concerns that PEEP may reduce venous return, lower cardiac output, and impair the chances of successful defibrillation. However, emerging experimental and observational data suggest that PEEP may actually improve oxygenation, cardiac output, oxygen delivery, and rates of ROSC during CPR.

We hypothesize that applying PEEP during CPR improves neurologically favorable survival. Given its simplicity, negligible cost, and widespread availability, PEEP has the potential to enhance outcomes from cardiac arrest in a scalable and resource-efficient manner.

Objective To determine whether, during CPR with manual ventilation and after placement of a supraglottic airway device (SAD) or endotracheal tube (ETT), using a valve that generates 8 cm H₂O PEEP compared with a sham valve providing zero end-expiratory pressure (ZEEP) improves neurological outcomes at discharge.

Study design The REVIVE-PEEP study is an investigator-initiated, pragmatic, registry-based, multicenter, parallel-group, triple-blind randomized controlled superiority clinical trial in the ARREST registry.

Study population The principal stratum comprises adult patients with out-of-hospital cardiac arrest (OHCA) in whom advanced airway management is performed, defined by placement of a SAD or ETT, who subsequently undergo manual positive-pressure ventilation during CPR. The target sample size within this principal stratum is 2,400 patients.

Intervention Participating ambulance services will use pre-assembled CPR kits, containing a bag-valve-mask system with either a PEEP valve or a sham valve. These kits will be 1:1 pre-randomized, with the PEEP valve delivering 8 cm H₂O of PEEP and the sham valve delivering 0 cm H₂O of PEEP (i.e. ZEEP), alongside the standard advanced life support protocol.

Main study parameters/endpoints The primary estimand is the treatment effect on neurological outcome at hospital discharge, assessed by the utility-weighted modified Rankin Scale within the principal stratum. Key secondary outcomes include ROSC, 30-day survival and quality of life at 6 months.

02

Conditions studied

  • Cardiac Arrest, Out-Of-Hospital

Keywords

  • ventilation
  • advanced life support
  • PEEP
  • ZEEP
03

In context

Out-of-Hospital Cardiac Arrest

314 studies on the registry are indexed under Out-of-Hospital Cardiac Arrest; 93 are open to participants now.

This study's planned enrollment of 3,200 is above the median of 218 across 179 interventional studies indexed under Out-of-Hospital Cardiac Arrest.

Browse Out-of-Hospital Cardiac Arrest studies →

Lead sponsor

Jeroen van Eijk is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All adult patients with a OHCA who receive an advanced airway

Exclusion criteria

Exclusion Criteria:

  • Suspected traumatic cardiac arrest
  • Suspected cardiac arrest after drowning
  • Airway management and ventilation initiated with a non-study resuscitator by a provider from a non-participating ambulance service
  • Continuous use of mechanical ventilation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
3,200 participants (estimated)

Study arms

  • Experimental
    PEEP

    8 cm H2O of PEEP

    Device: Fixed PEEP Valve

  • Sham comparator
    ZEEP

    Device: Sham Valve

Interventions

  • DeviceFixed PEEP Valve

    8 cm H2O

  • DeviceSham Valve

    0 cm H2O of PEEP

    Also known as: ZEEP

06

What researchers measure

Primary outcomes

  1. Neurological outcomes

    uw-mRS

    Time frame: At hospital discharge (up to 30 days after the cardiac arrest)

07

Study locations

3 sites
  • RAV Noord-Holland Noord
    Alkmaar, Netherlands
  • Ambulance Amsterdam
    Amsterdam, Netherlands
  • RAV Flevoland, Gooi- en Vechtstreek
    Hilversum, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07905482
Lead sponsor
Jeroen van Eijk
Collaborators
Dutch Heart Foundation, Ambu A/S
Responsible party
Jeroen van Eijk (Coordinating Investigator, Amsterdam UMC, location VUmc) — Sponsor-investigator
First posted
Oct 29, 2026
Start date
Oct 5, 2026
Primary completion
Mar 5, 2029 (estimated)
Completion
Sep 5, 2029 (estimated)
Last update
Oct 29, 2026

Study contacts

Patrick Schober, MD, PhD
principal investigator · Amsterdam UMC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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