Cardiac Arrest, Out-Of-HospitalREVIVE-PEEPNCT07905482
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
A study testing Fixed PEEP Valve in people with Cardiac Arrest, Out-Of-Hospital, run by Jeroen van Eijk at 3 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital
- What is being tested?
- Fixed PEEP Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,200 participants
- Where
- 3 sitesNetherlands
- Study dates
- 5 Oct 2026to 5 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients with a OHCA who receive an advanced airway
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
RAV Noord-Holland Noord
Alkmaar
Ambulance Amsterdam
Amsterdam
RAV Flevoland, Gooi- en Vechtstreek
Hilversum
About this study
Official title: 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 Investigator-initiated, Pragmatic, Registry-based, Multicenter, Parallel-group, Triple-blind Randomized Controlled Superiority Clinical Trial in the ARREST Registry
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)?
Read more
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.
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Being tested
- Fixed PEEP Valve, Sham Valve
- Keywords
- ventilation, advanced life support, PEEP, ZEEP
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed PEEP ValveDevice
8 cm H2O
Sham ValveDevice
Also called ZEEP
0 cm H2O of PEEP
| Study group | Role | What they receive |
|---|---|---|
| PEEP | Experimental | 8 cm H2O of PEEP Receives: Device: Fixed PEEP Valve |
| ZEEP | Sham comparator | Not described Receives: Device: Sham Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcomes
uw-mRS
Measured: At hospital discharge (up to 30 days after the cardiac arrest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start5 Oct 2026
- Primary completion5 Mar 2029 (estimated)
- Study completion5 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeroen van Eijk
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation, Ambu A/S
- Responsible party
- Sponsor-investigator, Jeroen van Eijk, Amsterdam UMC, location VUmc
- Investigators
- Patrick Schober, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905482
- Sponsor's protocol ID
- NL-009273
- Acronym
- REVIVE-PEEP
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Investigator-initiated, Pragmatic, Registry-based, Multicenter, Parallel-group, Triple-blind Randomized Controlled Superiority Clinical Trial in the ARREST Registry
- ClinicalTrials.gov ID
- NCT07905482
- Acronym / sponsor ID
- REVIVE-PEEP / NL-009273
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Keywords
- ventilation, advanced life support, PEEP, ZEEP
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Jeroen van EijkUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation, Ambu A/S
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- 5 Mar 2029 (estimated)
- Study completion
- 5 Sep 2029 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP | Experimental | Device: Fixed PEEP Valve8 cm H2O of PEEP |
| ZEEP | Sham comparator | Device: Sham Valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients with a OHCA who receive an advanced airway
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed PEEP Valve8 cm H2O | Device | PEEP |
| Sham ValveAlso: ZEEP0 cm H2O of PEEP | Device | ZEEP |
Primary outcome
Neurological outcomes
Time frame: At hospital discharge (up to 30 days after the cardiac arrest)
uw-mRS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Registered ReportLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Arrest, Out-Of-Hospital
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Schober, MD, PhD principal investigator
Amsterdam UMC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed PEEP Valve in people with Cardiac Arrest, Out-Of-Hospital, run by Jeroen van Eijk at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological outcomes (time frame: At hospital discharge (up to 30 days after the cardiac arrest)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.