An interventional study of Ventilation Feedback Device (Active) and Control (Recording-Only) in Cardiac Arrest (CA) and Cardiopulmonary Resuscitation (CPR), sponsored by Jeroen van Eijk. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Jeroen van Eijk · Not applicable, Interventional, and Treatment
Adequate ventilation during cardiopulmonary resuscitation is essential to maintain oxygenated blood supply to vital organs, yet achieving guideline-adherent synchronous ventilation (two breaths per pause after 30 compressions, with sufficient expiratory tidal volume) remains difficult in practice.
In the prehospital setting, ventilation is delivered manually by resuscitator bag without measurement or feedback, and thoracic impedance data suggest that in 40-60% of ventilation pauses no ventilation is detected, with a dose-dependent association between successful ventilation and ROSC, survival, and neurological outcome in post-hoc analyses.
Visible chest rise, the current clinical guide, correlates poorly with delivered tidal volume. Real-time ventilation feedback devices (VFDs) have improved ventilation quality in manikin studies, but an ILCOR scoping review found only few, mostly observational or before-after, clinical studies and called for prospective evaluation. We therefore hypothesize that real-time, objective feedback on tidal volume and leakage improves guideline adherence compared with standard, unguided ventilation, in a randomized trial in the setting of a supraglottic airway and synchronous ventilation.
SUMMARY
Rationale: Effective ventilation is critical for maintaining oxygenation and carbon dioxide elimination during cardiopulmonary resuscitation (CPR). However, observational studies consistently show that adequate lung inflation is frequently not achieved during synchronous ventilation, in which two ventilations are delivered after every 30 chest compressions. The absence of real-time feedback during manual ventilation contributes to substantial variability in delivered tidal volumes and pressures, representing a potentially modifiable factor to improve ventilation quality and, potentially, patient outcomes.
Objective: The OXY-VENT study aims to determine whether the EOlife, a real-time ventilation feedback device (VFD) can enhance ventilation quality during CPR.
Study design: The OXY-VENT study is an investigator-initiated, single-center, open-label, parallel-group, randomized controlled superiority trial designed to evaluate the efficacy of a ventilation feedback intervention versus a control device in recording-only mode on ventilation quality during cardiac arrest.
Study population: Adult patients experiencing out-of-hospital cardiac arrest treated by regional ambulance services in Utrecht, the Netherlands. Patients are managed using synchronous ventilation following immediate placement of a supraglottic airway device.
Intervention: Upon activation of the VFD, participants are randomly assigned to receive ventilation in either active feedback mode (intervention) or recording-only mode (control).
Main study parameters/endpoints: The primary outcome is the proportion of pauses during which guideline-adherent ventilations are administered. This is defined as the delivery of two ventilations per pause, each with an expiratory tidal volume of 400-500 mL.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Although manikin studies suggest promising results, high-quality clinical evidence supporting the use of VFDs during cardiopulmonary resuscitation remains limited. Participation in this trial imposes minimal additional burden, as patients are unconscious at the time of inclusion and the intervention does not interfere with ongoing resuscitation efforts.
The VFD is integrated into the standard resuscitation workflow, ensuring that usual care is maintained in both study groups. The associated risks are considered negligible, as the device does not alter ventilation delivery but provides feedback only in the intervention arm, while operating in recording-only mode in the control arm.
Given the physiological rationale and prior evidence linking ventilation quality to improved outcomes, there is a plausible expectation that improved guideline adherence - the primary endpoint - may confer an individual benefit to the participant. Group allocation does not expose participants to differential risk beyond the presence or absence of feedback, and the study may additionally contribute to improved ventilation quality during resuscitation in future patients.
984 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's planned enrollment of 515 is above the median of 100 across 563 interventional studies indexed under Heart Arrest.
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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.
Participants receive resuscitation using the ventilation feedback device operating in feedback mode, in which real-time visual feedback is displayed to guide the provider toward a target expiratory tidal volume of 400-500 mL.
Device: Ventilation Feedback Device (Active)
Participants receive resuscitation using the same device operating in recording-only mode, in which ventilation parameters are recorded but no feedback is displayed to the provider.
Device: Control (Recording-Only)
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.
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.
Proportion of guideline-adherent ventilation pauses per resuscitation attempt
A ventilation pause is a compression pause during CPR in which rescue breaths are delivered. Guideline adherence per pause is defined as delivery of two ventilations, each with a device-measured expiratory tidal volume of 400-500 mL, per European Resuscitation Council recommendations. For each patient, the proportion of guideline-adherent pauses is calculated as the number of adherent pauses divided by the total analyzable pauses during the resuscitation attempt. The primary outcome is the mean of this patient-level proportion, averaged across all patients, compared between feedback and control groups.
Time frame: From enrollment to the end of treatment at day 1
Number of Participants with Prehospital Return of Spontaneous Circulation (ROSC)
Any return of spontaneous circulation (ROSC), defined per the Utstein Out-of-Hospital Cardiac Arrest Registry Template, at any point during the prehospital resuscitation attempt.
Time frame: From enrollment to the end of treatment at day 1
Number of Participants Surviving to 30 Days
Survival to 30 days
Time frame: From enrollment to day 30
Number of Participants with Favorable Neurological Outcome
Favorable neurological outcome, defined as a Modified Rankin Scale (mRS) score of 0-3, where 0 indicates no symptoms and 6 indicates death, assessed at hospital discharge or 30 days.
Time frame: From enrollment to hospital discharge or 30 days
Proportion of Guideline-Adherent Ventilations
Proportion (%) of ventilations with expiratory tidal volume 400-500 mL, per European Resuscitation Council recommendations, calculated across all ventilations pooled across patients during prehospital resuscitation. Device-recorded data, compared between feedback and control groups.
Time frame: From enrollment to the end of treatment at day 1
Expiratory Tidal Volume per Ventilation
Central tendency (mean or median) of expiratory tidal volume per ventilation, in milliliters (mL), calculated across all ventilations pooled across patients (not averaged per patient first). Device-recorded, compared between feedback and control groups.
Time frame: From enrollment to the end of treatment at day 1
Ventilation Leakage
Central tendency of gas leakage per ventilation, expressed as a percentage (%) of inspiratory tidal volume, calculated across all ventilations pooled across patients. Device-recorded, compared between feedback and control groups.
Time frame: From enrollment to the end of treatment at day 1
Ventilation Pause Duration
Duration of compression pauses in which ventilations are delivered, in seconds, calculated across all pauses pooled across patients. Device-recorded, compared between feedback and control groups.
Time frame: From enrollment to the end of treatment at day 1
Minute Ventilation
Inspiratory and expiratory minute volume, in liters per minute (L/min), calculated across all minutes pooled across patients. Device-recorded, compared between feedback and control groups.
Time frame: From enrollment to the end of treatment at day 1
Change in Ventilation Quality Over Time Within Resuscitation Attempts
Trend in the proportion (percentage-point change) of guideline-adherent ventilations across consecutive time intervals within a resuscitation attempt, pooled across patients. Device-recorded, compared between feedback and control groups.
Time frame: From enrollment to the end of treatment at day 1
EMS-Level Learning Curve in Ventilation Quality
Change in ventilation quality, expressed as percentage-point change in guideline adherence, at the EMS-provider level as a function of cumulative study exposure (number of cases performed). Device-recorded.
Time frame: Through study completion
Plan to share: No
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