NCT06939335 The Application of Positive End-Expiratory Pressure in Out-of-Hospital Cardiac Arrest: The Lazarus-PEEP Trial.
| NCT ID | NCT06939335 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Ghent |
| Condition | Cardiac Arrest (CA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2025-04-25 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 132 participants in total. It began in 2025-04-25 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Age: Adults aged 18 years and older. 2. Type of Cardiac Arrest: Patients who have experienced a non-traumatic out-of-hospital cardiac arrest. 3. CPR Administration: Patients receiving cardiopulmonary resuscitation from an advanced life support (ALS) team. 4. Intubation and Ventilation: Patients who are intubated and ventilated during resuscitation efforts. Exclusion Criteria: 1. Cardiac arrest in patient younger than 18 years of age. 2. Traumatic cardiac arrest, including drowning, penetrating or blunt injury, and burns. 3. Immediate Return of Spontaneous Circulation (ROSC): Patients who achieve ROSC before intubation and initiation of intubation. 4. Pregnancy. 5. Mechanical ventilation during arrest: patients already receiving mechanical ventilation at the moment of cardiac arrest, due to reasons other than their arrest, will be excluded. 6. Do Not Resuscitate (DNR) Orders: Patients with existing DNR orders or any advanced directive indicating that CPR should not be performed. 7. Failure to intubate: if intubation is unsuccessful, ventilation by any means (MBV, SGA) should take priority over the study protocol, and the patient is excluded. 8. Enrolment in Other Studies: Patients currently enrolled in another interventional clinical trial that could interfere with the outcomes of this study.
Contact & Investigator
Saïd Hachimi Idrissi, MD, PhD, Professor
PRINCIPAL INVESTIGATOR
UZ Gent
Frequently Asked Questions
Who can join the NCT06939335 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrest (CA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06939335 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 132 participants.
Is NCT06939335 currently recruiting?
Yes, NCT06939335 is actively recruiting participants. Contact the research team at thomas.tackaert@ugent.be for enrollment information.
Where is the NCT06939335 trial being conducted?
This trial is being conducted at Ostend, Belgium, Aalst, Belgium, Aalst, Belgium, Geraardsbergen, Belgium and 3 additional locations.
Who is sponsoring the NCT06939335 clinical trial?
NCT06939335 is sponsored by University Hospital, Ghent. The principal investigator is Saïd Hachimi Idrissi, MD, PhD, Professor at UZ Gent. The trial plans to enroll 132 participants.