PEEP Vs. ZEEP in Out-of-Hospital-Cardiac-Arrest

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06836830
• Lead Sponsor: Muehlenkreiskliniken, MKK

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.

Study Timeline

• Study First Submitted: 2025-01-21
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-15
• Study First Posted: 2025-02-20
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Study Start: 2025-03-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The return of spontaneous circulation (ROSC)	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).

Secondary Outcome Measures

Name	Time	Method
Re-Arrest-Rate	Upon hospital admission	Any need for chest compressions after ROSC (yes vs. no)
Death during pre-hospital care phase	Upon hospital admission	Any death during pre-hospital care phase (yes vs. no)
Hospital admission during ongoing resuscitation	at hospital admission	Need for chest-compressions at hospital admission (yes vs. no)
Hospital admission with spontaneous circulation	at hospital admission	Hospital admission with spontaneous circulation without need for chest compressions (yes vs. no)
SpO2 at hospital admission	at hospital admission	SpO2 at hospital admission (%)
FiO2 at hospital admission	at hospital admission	FiO2 at hospital admission (%)