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NCT07870551
The OXY-VENT Study
Conditions: Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 515
Sponsor: Jeroen van Eijk
Location: RAVU Bilthoven
Summary
During resuscitation after a cardiac arrest, providing effective breaths (ventilation) is essential to keep oxygen reaching the vital organs. Research shows that when breaths are given by hand during CPR, they often do not meet the recommended volume, and there is currently no way for ambulance personnel to know this in the moment.
The OXY-VENT study investigates whether a device that gives real-time feedback on ventilation can help ambulance personnel deliver breaths that better meet resuscitation guidelines, compared with using the same type of device without feedback (in recording-only mode).
Adult patients who suffer a cardiac arrest outside the hospital in the Utrecht region and are treated by ambulance personnel will be included in the study. Because these patients are unconscious and cannot give permission beforehand, and treatment must start immediately, the device is already built into the standard resuscitation equipment ambulance teams carry, so no extra steps are needed to take part. When switched on, the device randomly starts in one of two modes: one where it shows the ambulance provider real-time information about the breaths being given, and one where it records the same information without showing it. This determines which of the two study groups a patient is in.
The main question the study aims to answer is whether breaths given during resuscitation more often meet recommended targets when real-time feedback is shown, compared to when it is not. The study will also look at other outcomes, such as return of a heartbeat, survival, and recovery of brain function, although it is not specifically designed to show differences in these outcomes.
Eligibility Criteria
Inclusion Criteria:
All adults with OHCA will be included, regardless of rhythm, whether the cardiac arrest was witnessed, or whether bystander CPR was initiated.
Exclusion Criteria:
Pediatric and traumatic cardiac arrests are excluded.
Source: ClinicalTrials.gov (NCT07870551). StuddyBuddy aggregates publicly available trial information.