PEEP Vs. ZEEP in Out-of-Hospital-Cardiac-Arrest (PerAVent)

Muehlenkreiskliniken, MKK

Status: Not yet enrolling

Conditions: PEEP, Occult; Cardiac Arrest (CA); Ventilation Therapy; CPR

Treatments: Procedure: PEEP 5 mbar; Procedure: ZEEP 0 mbar

Study type: Interventional

Funder types: Other

Identifiers

NCT06836830

2024-1148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

600 participants in 2 patient groups

PEEP

Experimental group

Description:

PEEP Group (Intervention Group): Patients will receive mechanical ventilation with end-expiratory-pressure set at 5 mbar (PEEP).

Treatment:

Procedure: PEEP 5 mbar

ZEEP

Experimental group

Description:

ZEEP Group (Control Group): Patients will receive mechanical ventilation with end-expiratory-pressure set at 0 mbar (ZEEP).

Treatment:

Procedure: ZEEP 0 mbar