The Application of Positive End-Expiratory Pressure in Out-of-Hospital Cardiac Arrest: The Lazarus-PEEP Trial.

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Disposable PEEP Valve set at 5 cm H20.

    Device

    Ventilation 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

    Device

    Ventilation 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

132 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day one

Secondary outcomes

1

Survival to hospital admission

Time frame
Day one
2

Survival to hospital discharge

Time frame
From enrolment until hospital discharge or death - whichever happens first. Average hospitalisation after OHCA is 24 days.
3

30-day survival

Time frame
From enrollment to the end of 30 days.
4

90-day survival

Time frame
From enrollment to the end of 90 days.

Other outcomes

1

Airflow during ventilation

The Sensirion SFM3200AW flow sensor will measure airflow during cardiopulmonary resuscitation, measured in ml.

Time frame
Periprocedural
2

Airway pressure during ventilation

The Wika CPT2500 sensor will measure airway pressure during cardiopulmonary resuscitation, measured in mbar.

Time frame
Periprocedural
3

Occurence of potential adverse effects

The incidence of barotrauma, including pneumothorax and pneumomediastinum

Time frame
Day one
4

Capnography

the ZOLL® X Series® monitor-defibrillator will be used to collect capnography data during cardiopulmonary resuscitation, measured in mmHg.

Time frame
Periprocedural

Sponsors and contacts

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