About this trial
The goal of this clinical trial is to learn whether using Positive End-Expiratory Pressure (PEEP) during cardiopulmonary resuscitation (CPR) improves outcomes for adults who experience out-of-hospital cardiac arrest, a condition where the heart suddenly stops beating. PEEP is used during ventilation, which may enhance oxygen levels by keeping the airways open throughout CPR.
This study aims to determine if using PEEP during CPR helps restart the heart more effectively, improves survival rates, and enhances survival with good neurologic outcomes after a cardiac arrest compared to standard CPR without PEEP.
Researchers will randomly assign participants to one of two groups: one receiving CPR with PEEP set at 5 cm of water pressure and the other receiving standard CPR without PEEP. Participants will be treated by emergency medical teams trained in advanced life support, and specialised sensors will measure airflow and airway pressure during resuscitation.
Additionally, the study will evaluate potential side effects associated with PEEP, such as increased pressure within the chest or lung injuries. Findings from this trial will guide recommendations on the usage of PEEP in standard CPR practices to potentially improve patient outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: Adults aged 18 years and older.
Type of Cardiac Arrest: Patients who have experienced a non-traumatic out-of-hospital cardiac arrest.
CPR Administration: Patients receiving cardiopulmonary resuscitation from an advanced life support (ALS) team.
Intubation and Ventilation: Patients who are intubated and ventilated during resuscitation efforts.
Disqualifiers
Cardiac arrest in patient younger than 18 years of age.
Traumatic cardiac arrest, including drowning, penetrating or blunt injury, and burns.
Immediate Return of Spontaneous Circulation (ROSC): Patients who achieve ROSC before intubation and initiation of intubation.
Pregnancy.
Trial design
Parallel
Treatments tested in this trial
Disposable PEEP Valve set at 5 cm H20.
DeviceVentilation during cardiac arrest with an adult Resuscitation Bag with a pressure relief valve set at 40 cm H20 and a 22 mm disposable PEEP Valve set at 5 cm H20.
Controle
DeviceVentilation during cardiac arrest with an adult Resuscitation Bag with a pressure relief valve set at 40 cm H20 without a disposable PEEP Valve.
Treatment groups
Trial outcomes
Primary outcomes
Return of spontaneous circulation (ROSC)
The occurrence of Return of spontaneous circulation (ROSC), defined as the return of sustained spontaneous circulation for at least 20 minutes per ERC guidelines
Secondary outcomes
Survival to hospital admission
Survival to hospital discharge
30-day survival
90-day survival
Other outcomes
Airflow during ventilation
The Sensirion SFM3200AW flow sensor will measure airflow during cardiopulmonary resuscitation, measured in ml.
Airway pressure during ventilation
The Wika CPT2500 sensor will measure airway pressure during cardiopulmonary resuscitation, measured in mbar.
Occurence of potential adverse effects
The incidence of barotrauma, including pneumothorax and pneumomediastinum
Capnography
the ZOLL® X Series® monitor-defibrillator will be used to collect capnography data during cardiopulmonary resuscitation, measured in mmHg.
Sponsors and contacts
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