Cardiac Arrest (CA)OXY-VENTNCT07870551
The OXY-VENT Study
A study testing Ventilation Feedback Device (Active) in people with Cardiac Arrest (CA) and Cardiopulmonary Resuscitation (CPR), run by Jeroen van Eijk at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
- What is being tested?
- Ventilation Feedback Device (Active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2027to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults with OHCA will be included, regardless of rhythm, whether the cardiac arrest was witnessed, or whether bystander CPR was initiated.
Who cannot join
- Pediatric and traumatic cardiac arrests are excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Patrick Schober, MD, PhD contact
Netherlands1 site
RAVU
Bilthoven, 3723BC
René Boomars, Msc, r.boomars@ravu.nl
About this study
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.
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.
Read the detailed description
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.
- Being tested
- Ventilation Feedback Device (Active), Control (Recording-Only)
- Keywords
- ventilation, cardiopulmonary resuscitation, ventilation feedback device, advanced life support
- Medical subject headings
- Heart Arrest, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation Feedback Device (Active)Device
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)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Feedback Group | Experimental | 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. Receives: Device: Ventilation Feedback Device (Active) |
| Recording-Only (Control) Group | Active comparator | 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. Receives: Device: Control (Recording-Only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at day 1
Secondary outcomes (8)
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.
Measured: From enrollment to the end of treatment at day 1
Number of Participants Surviving to 30 Days
Survival to 30 days
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to receive ventilation with real-time feedback (intervention) or with the same device operating in recording-only mode (control). Randomization is performed automatically by the study device itself: upon activation, the device randomly initiates in either feedback or recording-only mode and remains in the assigned mode for the first hour of use to ensure consistent treatment allocation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 515 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeroen van Eijk
- Sponsor type
- University, hospital or other
- Collaborators
- Archeon Medical
- Responsible party
- Sponsor-investigator, Jeroen van Eijk, Amsterdam UMC, location VUmc
- Investigators
- Patrick Schober, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870551
- Sponsor's protocol ID
- NL-011106
- Other IDs
- NL-011106
- Acronym
- OXY-VENT
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07870551
- Acronym / sponsor ID
- OXY-VENT / NL-011106
- Keywords
- ventilation, cardiopulmonary resuscitation, ventilation feedback device, advanced life support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 515 participants (estimated)
- Lead sponsor
- Jeroen van EijkUniversity, hospital or other
- Collaborators
- Archeon Medical
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to receive ventilation with real-time feedback (intervention) or with the same device operating in recording-only mode (control). Randomization is performed automatically by the study device itself: upon activation, the device randomly initiates in either feedback or recording-only mode and remains in the assigned mode for the first hour of use to ensure consistent treatment allocation.
| Arm | Type | Receives |
|---|---|---|
| Feedback Group | Experimental | Device: Ventilation Feedback Device (Active)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. |
| Recording-Only (Control) Group | Active comparator | Device: Control (Recording-Only)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults with OHCA will be included, regardless of rhythm, whether the cardiac arrest was witnessed, or whether bystander CPR was initiated.
Key exclusion criteria (1 listed)
- Pediatric and traumatic cardiac arrests are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Feedback Group |
| 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. | Device | Recording-Only (Control) Group |
Primary outcome
Proportion of guideline-adherent ventilation pauses per resuscitation attempt
Time frame: From enrollment to the end of treatment at day 1
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.
8 secondary outcomes
Number of Participants with Prehospital Return of Spontaneous Circulation (ROSC)
Time frame: From enrollment to the end of treatment at day 1
Number of Participants Surviving to 30 Days
Time frame: From enrollment to day 30
Number of Participants with Favorable Neurological Outcome
Time frame: From enrollment to hospital discharge or 30 days
Proportion of Guideline-Adherent Ventilations
Time frame: From enrollment to the end of treatment at day 1
Expiratory Tidal Volume per Ventilation
Time frame: From enrollment to the end of treatment at day 1
Ventilation Leakage
Time frame: From enrollment to the end of treatment at day 1
Ventilation Pause Duration
Time frame: From enrollment to the end of treatment at day 1
Minute Ventilation
Time frame: From enrollment to the end of treatment at day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Schober, MD, PhD contact
Patrick Schober, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation Feedback Device (Active) in people with Cardiac Arrest (CA) and Cardiopulmonary Resuscitation (CPR), run by Jeroen van Eijk at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeroen A. van Eijk, MD (+31 020 566 59 69, j.vaneijk1@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of guideline-adherent ventilation pauses per resuscitation attempt (time frame: From enrollment to the end of treatment at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.