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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.
Official title: The OXY-VENT Study: an Investigator-initiated, Single-center, Parallel-group, Randomized Controlled Superiority Trial of Real-time Ventilation Feedback Versus Control to Improve Ventilation Quality in Adults With Out-of-hospital Cardiac Arrest.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
515
Start Date
2026-10-01
Completion Date
2028-06-01
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
Ventilation Feedback Device (Active)
The same flow sensor and device measure inspiratory and expiratory tidal volume, leakage, and ventilation timing, connected between the resuscitator bag and airway device. In feedback mode, the device displays real-time visual feedback to guide the provider toward a target expiratory tidal volume of 400-500 mL.
Control (Recording-Only)
A ventilation feedback device integrated into standard resuscitation equipment, used during out-of-hospital cardiac arrest. The device measures inspiratory and expiratory tidal volume, leakage, and ventilation timing via a flow sensor connected between the resuscitator bag and airway device. In this arm, the device is randomly initiated in recording-only mode, recording the same ventilation parameters without displaying any feedback to the provider.
Locations (1)
RAVU
Bilthoven, Netherlands