PEEP 5 mbar versus ZEEP ventilation during out-of-hospital cardiac arrest
Peri-Arrest Ventilation With Positive End-Expiratory-Pressure vs. Zero End-Expiratory-Pressure in Out-of-Hospital-Cardiac-Arrest
This study will test whether using PEEP at 5 mbar instead of zero PEEP during mechanical ventilation helps adults with out-of-hospital cardiac arrest regain spontaneous circulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Muehlenkreiskliniken, MKK Academic / other |
| Locations | 3 sites (Gütersloh, North Rhine-Westphalia and 2 other locations) |
| Trial ID | NCT06836830 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, cluster-randomized trial run through regional emergency medical services in three German districts. Adult patients with non-traumatic out-of-hospital cardiac arrest who receive mechanical ventilation via an airway device are enrolled and treated according to the cluster's assigned strategy: PEEP 5 mbar or ZEEP 0 mbar. The primary outcome is the rate of return of spontaneous circulation (ROSC); secondary outcomes include re-arrest, prehospital death, hospital admission status, peripheral oxygen saturation, and end-tidal CO2 at hospital arrival. Clusters (districts) are randomized to one ventilation strategy to allow pragmatic comparison during routine prehospital resuscitation.
Who should consider this trial
Good fit: Adults aged 18 or older with non-traumatic out-of-hospital cardiac arrest who are receiving mechanical ventilation through an airway device are the intended participants.
Not a fit: Patients under 18, those with traumatic cardiac arrest, people without cardiac arrest, or cases where resuscitation is withheld (for example due to a DNR order) are excluded and would not be candidates for benefit from this protocol.
Why it matters
Potential benefit: If successful, using 5 mbar PEEP could increase the chance of return of spontaneous circulation and improve early oxygenation during prehospital resuscitation.
How similar studies have performed: Smaller physiological studies and in-hospital observations have shown that PEEP can change oxygenation and hemodynamics during CPR, but large randomized trials in out-of-hospital cardiac arrest are limited and the approach is not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults \>= 18 years * non-traumatic OHCA * mechanical ventilation via airway device Exclusion Criteria: * Patients \< 18 years, * traumatic cause of OHCA, * no cardiac arrest, withholding of resuscitation (e.g. Do-Not-Resuscitate orders)
Where this trial is running
Gütersloh, North Rhine-Westphalia and 2 other locations
- Emergency Medical Services — Gütersloh, North Rhine-Westphalia, Germany (Recruiting)
- JWK Minden — Minden, North Rhine-Westphalia, Germany (Recruiting)
- Emergency Medical Services — Osnabrück, Germany (Recruiting)
Study contacts
- Study coordinator: Gerrit Jansen, PD Dr. med.
- Email: gerrit.jansen@muehlenkreiskliniken.de
- Phone: +49 571-790-54401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.