Ventilation TherapyPerAVentNCT06836830
PEEP vs. ZEEP in Out-of-Hospital-Cardiac-Arrest
A study testing PEEP 5 mbar and ZEEP 0 mbar in people with Ventilation Therapy and PEEP, Occult, run by Muehlenkreiskliniken, MKK at 3 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilation Therapy, PEEP, Occult, CPR
- What is being tested?
- PEEP 5 mbar and ZEEP 0 mbar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Jun 2025to 31 Oct 2026
- 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
- Adults >= 18 years
- non-traumatic OHCA
- mechanical ventilation via airway device
Who cannot join
- Patients < 18 years,
- traumatic cause of OHCA,
- no cardiac arrest, withholding of resuscitation (e.g. Do-Not-Resuscitate orders)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Emergency Medical Services
Gütersloh, North Rhine-Westphalia, 33324
Julia Johanna Grannemann, MD, MSc, +491706765460, j.grannemann@kreis-guetersloh.de
Bernd Strickmann, MD, b.strickmann@kreis-guetersloh.de
- Recruiting
JWK Minden
Minden, North Rhine-Westphalia, 32429
Jochen Hinkelbein, MD
- Recruiting
Emergency Medical Services
Osnabrück
About this study
Official title: Peri-Arrest Ventilation With Positive End-Expiratory-Pressure vs. Zero End-Expiratory-Pressure in Out-of-Hospital-Cardiac-Arrest
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.
Read the detailed description
This is a prospective, multicenter, cluster-randomized controlled trial conducted across emergency medical services (EMS) in the regions of Guetersloh, Minden-Luebbecke and Osnabrueck. Adult patients (>= 18 years) with OHCA who are undergoing mechanical ventilation through an airway device will be enrolled. The clusters (regional district) will be randomized into two groups: one group will receive ventilation with PEEP set at 5 mbar (intervention group), while the other group will receive ventilation with ZEEP (control group). The study's primary endpoint is the rate of ROSC. Secondary endpoints include rate of re-arrest, death during pre-hospital care phase, hospital admission during ongoing resuscitation, hospital admission with spontaneous circulation, peripheral oxygen saturation and end tidal CO2 at hospital admission.
- Conditions
- Ventilation Therapy, PEEP, Occult, CPR, Cardiac Arrest (CA)
- Being tested
- PEEP 5 mbar, ZEEP 0 mbar
- Keywords
- Cardiac Arrest, Positive End-Expiratory Pressure, Zero End-Expiratory Pressure, Ventilation, Randomized Controlled Trial, Emergency Medicine, Resuscitation, CPR
- Medical subject headings
- Positive-Pressure Respiration, Intrinsic, Heart Arrest, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP 5 mbarProcedure or surgery
Positiv-End-Expiratory Pressure
ZEEP 0 mbarProcedure or surgery
Zero-End-Expiratory Pressure
| Study group | Role | What they receive |
|---|---|---|
| PEEP | Experimental | PEEP Group (Intervention Group): Patients will receive mechanical ventilation with end-expiratory-pressure set at 5 mbar (PEEP). Receives: Procedure: PEEP 5 mbar |
| ZEEP | Experimental | ZEEP Group (Control Group): Patients will receive mechanical ventilation with end-expiratory-pressure set at 0 mbar (ZEEP). Receives: Procedure: ZEEP 0 mbar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During or after resuscitation
Secondary outcomes (6)
Re-Arrest-Rate
Any need for chest compressions after ROSC (yes vs. no)
Measured: Upon hospital admission
Death during pre-hospital care phase
Any death during pre-hospital care phase (yes vs. no)
Measured: Upon hospital admission
Hospital admission during ongoing resuscitation
Need for chest-compressions at hospital admission (yes vs. no)
Measured: at hospital admission
Hospital admission with spontaneous circulation
Hospital admission with spontaneous circulation without need for chest compressions (yes vs. no)
Measured: at hospital admission
SpO2 at hospital admission
SpO2 at hospital admission (%)
Measured: at hospital admission
FiO2 at hospital admission
FiO2 at hospital admission (%)
Measured: at hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilation TherapyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muehlenkreiskliniken, MKK
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerrit Jansen, Muehlenkreiskliniken, MKK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836830
- Sponsor's protocol ID
- 2024-1148
- Acronym
- PerAVent
- Status last verified
- Aug 2025
- First submitted
- 21 Jan 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41566395
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Arrest Ventilation With Positive End-Expiratory-Pressure vs. Zero End-Expiratory-Pressure in Out-of-Hospital-Cardiac-Arrest
- ClinicalTrials.gov ID
- NCT06836830
- Acronym / sponsor ID
- PerAVent / 2024-1148
- Conditions
- Ventilation Therapy, PEEP, Occult, CPR, Cardiac Arrest (CA)
- Keywords
- Cardiac Arrest, Positive End-Expiratory Pressure, Zero End-Expiratory Pressure, Ventilation, Randomized Controlled Trial, Emergency Medicine, Resuscitation, CPR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Muehlenkreiskliniken, MKKUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 20 Feb 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.
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.
Detailed description
This is a prospective, multicenter, cluster-randomized controlled trial conducted across emergency medical services (EMS) in the regions of Guetersloh, Minden-Luebbecke and Osnabrueck. Adult patients (>= 18 years) with OHCA who are undergoing mechanical ventilation through an airway device will be enrolled. The clusters (regional district) will be randomized into two groups: one group will receive ventilation with PEEP set at 5 mbar (intervention group), while the other group will receive ventilation with ZEEP (control group). The study's primary endpoint is the rate of ROSC. Secondary endpoints include rate of re-arrest, death during pre-hospital care phase, hospital admission during ongoing resuscitation, hospital admission with spontaneous circulation, peripheral oxygen saturation and end tidal CO2 at hospital admission.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP | Experimental | Procedure: PEEP 5 mbarPEEP Group (Intervention Group): Patients will receive mechanical ventilation with end-expiratory-pressure set at 5 mbar (PEEP). |
| ZEEP | Experimental | Procedure: ZEEP 0 mbarZEEP Group (Control Group): Patients will receive mechanical ventilation with end-expiratory-pressure set at 0 mbar (ZEEP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults >= 18 years
- non-traumatic OHCA
- mechanical ventilation via airway device
Key exclusion criteria (3 listed)
- Patients < 18 years,
- traumatic cause of OHCA,
- no cardiac arrest, withholding of resuscitation (e.g. Do-Not-Resuscitate orders)
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 |
|---|---|---|
| PEEP 5 mbarPositiv-End-Expiratory Pressure | Procedure or surgery | PEEP |
| ZEEP 0 mbarZero-End-Expiratory Pressure | Procedure or surgery | ZEEP |
Primary outcome
The return of spontaneous circulation (ROSC)
Time frame: During or after resuscitation
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).
6 secondary outcomes
Re-Arrest-Rate
Time frame: Upon hospital admission
Death during pre-hospital care phase
Time frame: Upon hospital admission
Hospital admission during ongoing resuscitation
Time frame: at hospital admission
Hospital admission with spontaneous circulation
Time frame: at hospital admission
SpO2 at hospital admission
Time frame: at hospital admission
FiO2 at hospital admission
Time frame: at hospital admission
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 6 Aug 2025.
- Derived from this study: PubMed 41566395Vaseekaran 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.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP 5 mbar and ZEEP 0 mbar in people with Ventilation Therapy and PEEP, Occult, run by Muehlenkreiskliniken, MKK at 3 sites in Germany.
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 3 inclusion and 3 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 6 Aug 2025. 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 Germany. 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.
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 Gerrit Jansen, PD Dr. med. (+49 571-790-54401, gerrit.jansen@muehlenkreiskliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The return of spontaneous circulation (ROSC) (time frame: During or after resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06836830, which also lists 1 linked publication.
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 6 Aug 2025.