Clinical trial NCT06836830: PEEP Vs. ZEEP in Out-of-Hospital-Cardiac-Arrest
Official title: Peri-Arrest Ventilation with Positive End-Expiratory-Pressure Vs. Zero End-Expiratory-Pressure in Out-of-Hospital-Cardiac-Arrest
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Muehlenkreiskliniken, MKK
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility 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)

Primary outcomes:
measure: The return of spontaneous circulation (ROSC)
timeFrame: During or after resuscitation
Secondary outcomes:
measure: Re-Arrest-Rate
timeFrame: Upon hospital admission
measure: Death during pre-hospital care phase
timeFrame: Upon hospital admission
measure: Hospital admission during ongoing resuscitation
timeFrame: at hospital admission
measure: Hospital admission with spontaneous circulation
timeFrame: at hospital admission
measure: SpO2 at hospital admission
timeFrame: at hospital admission
measure: FiO2 at hospital admission
timeFrame: at hospital admission
Other outcomes:
Locations:
Study officials:
References: