Cardiac Arrest (CA)Phase 3Lazarus-PEEPNCT06939335
The Application of Positive End-Expiratory Pressure in Out-of-Hospital Cardiac Arrest: The Lazarus-PEEP Trial.
A Phase 3 study testing Disposable PEEP Valve set at 5 cm H20. in people with Cardiac Arrest (CA) and Out-of-hospital Cardiac Arrest (OHCA), run by University Hospital, Ghent at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA), Out-of-hospital Cardiac Arrest (OHCA), Positive End-expiratory Pressure (PEEP)
- What is being tested?
- Disposable PEEP Valve set at 5 cm H20.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 25 Apr 2025to 1 Feb 2027
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Belgium6 sites, 6 recruiting
- Recruiting
AZORG: campus Merestraat
Aalst, B-9300
AZORG: campus Merestraat, 0032 53 76 40 06, spoedopname.asz@azorg.be
Jolien Volcke, MD
- Recruiting
AZORG: Campus Moorselbaan
Aalst, B-9300
AZORG: Campus Moorselbaan, 0032 53 72 49 96
Thomas Tackaert, MD
- Recruiting
AZORG: campus Geraardsbergen
Geraardsbergen, B-9500
AZORG: campus Geraardsbergen, 0032 54 43 27 11, spoedopname@azorg.be
Jolien Volcke, MD
- Recruiting
UZ Ghent
Ghent, B-9240
Spoedgevallendienst UZ Gent, 0032 9 332 50 24, secretariaatspoed@uzgent.be
Saïd Hachimi Hachimi Idrissi, MD, PhD, Professor
- Recruiting
AZ Zeno
Knokke, 8300
Urgentiegeneeskunde - spoed AZ Zeno Knokke-Heist, 0032 50 535 112, info@azzeno.be
Tom De Coninck, MD
- Recruiting
AZ Oostende
Ostend, West-Flandres, 8400
Maxim Vanwulpen, MD, PhD, 0032 59 41 40 80, maxim.vanwulpen@azoostende.be
Maxim Vanwulpen, MD, PhD
France1 site
- Active, not recruiting
Centre hospitalier universitaire (CHU) Besançon-Franche-Comté
Besançon
About this study
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.
Read more
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.
Read the detailed description
Introduction: Sudden cardiac arrest is a significant cause of mortality, with an estimated annual incidence of 84 cases per 100,000 individuals in Europe. Effective cardiopulmonary resuscitation (CPR), including proper ventilation, is crucial for survival. However, the interplay between ventilation and circulation during CPR is complex and not fully understood. While ventilation is necessary for oxygenation, excessive hyperventilation and high intrathoracic pressures can be detrimental. Positive End-Expiratory Pressure (PEEP) may improve oxygenation and ventilation by maintaining alveolar patency and improving oxygenation. Previous observational studies have suggested that PEEP might enhance the rate of Return of Spontaneous Circulation (ROSC) and improve short-term outcomes. However, no prospective randomised clinical trials have been conducted to confirm these findings. The Lazarus-PEEP trial aims to address this gap by evaluating the efficacy and safety of PEEP during CPR for out-of-hospital cardiac arrest (OHCA) patients.
Methodology: The study will be conducted at Ghent University Hospital and three non-university hospitals in Belgium, enrolling adult patients who experience non-traumatic OHCA and are intubated and ventilated during resuscitation efforts by an advanced life support (MUG) team. Participants will be randomised to receive either PEEP at 5 cm H2O or no PEEP (0 cm H2O) during CPR. Custom-built sensors will measure tracheal airflow and pressure, while additional data on CPR quality and patient outcomes will be collected. The trial's primary outcome measure is the rate of ROSC, with secondary outcomes including survival to hospital admission and discharge, as well as neurological outcomes at discharge.
Outcome: The study will evaluate the effectiveness of PEEP in improving ROSC rates, short-term survival, and neurological outcomes. Safety profiles will also be examined, focusing on adverse effects such as barotrauma and increased intrathoracic pressures. Comprehensive data collection will provide insights into the physiological impact of PEEP during CPR and its feasibility in a pre-hospital setting.
Conclusion: The Lazarus-PEEP trial aims to gather strong evidence on the potential advantages and risks of utilizing PEEP during CPR for OHCA patients. The results will inform evidence-based guidelines and enhance resuscitation practices, potentially leading to improved patient outcomes. The findings will be disseminated through influential journals, major scientific conferences, and public data-sharing platforms to ensure widespread accessibility and impact.
- Conditions
- Cardiac Arrest (CA), Out-of-hospital Cardiac Arrest (OHCA), Positive End-expiratory Pressure (PEEP), Ventilation During Resuscitation
- Being tested
- Disposable PEEP Valve set at 5 cm H20., Controle
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Controle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day one
Secondary outcomes (5)
Survival to hospital admission
Measured: Day one
Survival to hospital discharge
Measured: From enrolment until hospital discharge or death - whichever happens first. Average hospitalisation after OHCA is 24 days.
30-day survival
Measured: From enrollment to the end of 30 days.
90-day survival
Measured: From enrollment to the end of 90 days.
Neurological outcome at discharge
Neurological outcome at discharge, as defined by the Cerebral Performance Category Scale.
Measured: From enrolment until hospital discharge or death - whichever happens first. Average hospitalisation after OHCA is 24 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start25 Apr 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter parallel controlled randomised clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saïd Hachimi Idrissi, MD, PhD, Professor, Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939335
- Sponsor's protocol ID
- ONZ-2024-0496
- Acronym
- Lazarus-PEEP
- Status last verified
- Jan 2026
- First submitted
- 31 Mar 2025
- Last updated
- 21 Jan 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Positive End-Expiratory Pressure in Out-of-Hospital Cardiac Arrest: The Lazarus-PEEP Trial.
- ClinicalTrials.gov ID
- NCT06939335
- Acronym / sponsor ID
- Lazarus-PEEP / ONZ-2024-0496
- Conditions
- Cardiac Arrest (CA), Out-of-hospital Cardiac Arrest (OHCA), Positive End-expiratory Pressure (PEEP), Ventilation During Resuscitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 22 Apr 2025 (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 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.
Detailed description
Introduction: Sudden cardiac arrest is a significant cause of mortality, with an estimated annual incidence of 84 cases per 100,000 individuals in Europe. Effective cardiopulmonary resuscitation (CPR), including proper ventilation, is crucial for survival. However, the interplay between ventilation and circulation during CPR is complex and not fully understood. While ventilation is necessary for oxygenation, excessive hyperventilation and high intrathoracic pressures can be detrimental. Positive End-Expiratory Pressure (PEEP) may improve oxygenation and ventilation by maintaining alveolar patency and improving oxygenation. Previous observational studies have suggested that PEEP might enhance the rate of Return of Spontaneous Circulation (ROSC) and improve short-term outcomes. However, no prospective randomised clinical trials have been conducted to confirm these findings. The Lazarus-PEEP trial aims to address this gap by evaluating the efficacy and safety of PEEP during CPR for out-of-hospital cardiac arrest (OHCA) patients.
Methodology: The study will be conducted at Ghent University Hospital and three non-university hospitals in Belgium, enrolling adult patients who experience non-traumatic OHCA and are intubated and ventilated during resuscitation efforts by an advanced life support (MUG) team. Participants will be randomised to receive either PEEP at 5 cm H2O or no PEEP (0 cm H2O) during CPR. Custom-built sensors will measure tracheal airflow and pressure, while additional data on CPR quality and patient outcomes will be collected. The trial's primary outcome measure is the rate of ROSC, with secondary outcomes including survival to hospital admission and discharge, as well as neurological outcomes at discharge.
Outcome: The study will evaluate the effectiveness of PEEP in improving ROSC rates, short-term survival, and neurological outcomes. Safety profiles will also be examined, focusing on adverse effects such as barotrauma and increased intrathoracic pressures. Comprehensive data collection will provide insights into the physiological impact of PEEP during CPR and its feasibility in a pre-hospital setting.
Conclusion: The Lazarus-PEEP trial aims to gather strong evidence on the potential advantages and risks of utilizing PEEP during CPR for OHCA patients. The results will inform evidence-based guidelines and enhance resuscitation practices, potentially leading to improved patient outcomes. The findings will be disseminated through influential journals, major scientific conferences, and public data-sharing platforms to ensure widespread accessibility and impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter parallel controlled randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Disposable PEEP Valve set at 5 cm H20.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. |
| Controle | Active comparator | Device: ControleVentilation during cardiac arrest with an adult Resuscitation Bag with a pressure relief valve set at 40 cm H20 without a disposable PEEP Valve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Disposable PEEP Valve set at 5 cm H20.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. | Device | Intervention |
| ControleVentilation 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 |
Primary outcome
Return of spontaneous circulation (ROSC)
Time frame: Day one
The occurrence of Return of spontaneous circulation (ROSC), defined as the return of sustained spontaneous circulation for at least 20 minutes per ERC guidelines
5 secondary outcomes
Survival to hospital admission
Time frame: Day one
Survival to hospital discharge
Time frame: From enrolment until hospital discharge or death - whichever happens first. Average hospitalisation after OHCA is 24 days.
30-day survival
Time frame: From enrollment to the end of 30 days.
90-day survival
Time frame: From enrollment to the end of 90 days.
Neurological outcome at discharge
Time frame: From enrolment until hospital discharge or death - whichever happens first. Average hospitalisation after OHCA is 24 days.
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 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Saïd Hachimi Idrissi, MD, PhD, Professor principal investigator
UZ Gent
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Disposable PEEP Valve set at 5 cm H20. in people with Cardiac Arrest (CA) and Out-of-hospital Cardiac Arrest (OHCA), run by University Hospital, Ghent at 7 sites in 2 countries.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Thomas Tackaert, MD (0032 53 72 49 96, thomas.tackaert@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of spontaneous circulation (ROSC) (time frame: Day one). 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 21 Jan 2026.