Cardiac Arrest (CA), CPR, PEEP, Occult, Ventilation Therapy
Conditions
Keywords
Cardiac Arrest, Positive End-Expiratory Pressure, Zero End-Expiratory Pressure, Ventilation, Randomized Controlled Trial, Emergency Medicine, Resuscitation, CPR
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.
Interventions
PROCEDUREPEEP 5 mbar
Positiv-End-Expiratory Pressure
PROCEDUREZEEP 0 mbar
Zero-End-Expiratory Pressure
Sponsors
Muehlenkreiskliniken, MKK
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
| 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) |
| Re-Arrest-Rate | Upon hospital admission | Any need for chest compressions after ROSC (yes vs. no) |
Countries
Germany
Contacts
Primary ContactGerrit Jansen, PD Dr. med.
Backup ContactJochen Hinkelbein, Prof. Dr. med.
Outcome results
None listed