Cardiac ArrestNCT06528704
The Impact of Real Time Ventilation Feedback on Ventilation Rate and Tidal Volume During Cardiac Arrest.
A study testing Ventilation feedback device in people with Cardiac Arrest, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
During out-of-hospital cardiopulmonary resuscitation, patient are first ventilated without ventilation feedback (but with a flowsensor connected), hereafter patients are ventilated with the use of ventilation feedback. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Ventilation feedback device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- 20 May 2024to 31 Dec 2026
- 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
- -
Who cannot join
- Traumatic cardiac arrest Inability to intubate patient
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Said Hachimi-Idrissi, MD contact
Belgium2 sites, 2 recruiting
- Recruiting
Ghent University Hospital
Ghent
Said Hachimi-Idrissi, MD
- Not yet recruiting
AZ Zeno
Knokke, West-Vlaanderen, 8301
Maxim Vanwulpen, MD, 3250 535 112
About this study
During out-of-hospital cardiopulmonary resuscitation, patient are first ventilated without ventilation feedback (but with a flowsensor connected), hereafter patients are ventilated with the use of ventilation feedback.
Read the detailed description
During cardiac arrest, patients are intubated, ventilation is performed using a manual resuscitator. Hereafeter, a flowsensor is connected. During the first cycle, patients are ventilated without any feedback (whilst the sensor is recording the delivered ventilation). During the second cycle, realtime delivered flow is shown on the screen, informing the user on the delivered ventilation volume and ventilation rate. Data is saved automatically after use.
- Conditions
- Cardiac Arrest
- Being tested
- Ventilation feedback device
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation feedback deviceDevice
Device showing delivered ventilation frequency and volume.
| Study group | Role | What they receive |
|---|---|---|
| Ventilation feedback | Experimental | First, ventilation without feedback, hereafter ventilation with feedback Receives: Device: Ventilation feedback device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivered ventilation frequency
Measured ventilation frequency (with or without ventilation feedback)
Measured: 2 minutes
Delivered ventilation volume
Measured ventilation volume (with or without ventilation feedback)
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start20 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528704
- Sponsor's protocol ID
- ONZ-2023-0613
- Status last verified
- Jan 2025
- First submitted
- 22 May 2024
- Last updated
- 15 Jan 2025
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Real Time Ventilation Feedback on Ventilation Rate and Tidal Volume During Cardiac Arrest.
- ClinicalTrials.gov ID
- NCT06528704
- Acronym / sponsor ID
- ONZ-2023-0613
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jul 2024 (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.
During out-of-hospital cardiopulmonary resuscitation, patient are first ventilated without ventilation feedback (but with a flowsensor connected), hereafter patients are ventilated with the use of ventilation feedback.
Detailed description
During cardiac arrest, patients are intubated, ventilation is performed using a manual resuscitator. Hereafeter, a flowsensor is connected. During the first cycle, patients are ventilated without any feedback (whilst the sensor is recording the delivered ventilation). During the second cycle, realtime delivered flow is shown on the screen, informing the user on the delivered ventilation volume and ventilation rate. Data is saved automatically after use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventilation feedback | Experimental | Device: Ventilation feedback deviceFirst, ventilation without feedback, hereafter ventilation with feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Traumatic cardiac arrest Inability to intubate patient
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 deviceDevice showing delivered ventilation frequency and volume. | Device | Ventilation feedback |
Primary outcome
Delivered ventilation frequency
Time frame: 2 minutes
Measured ventilation frequency (with or without ventilation feedback)
Delivered ventilation volume
Time frame: 2 minutes
Measured ventilation volume (with or without ventilation feedback)
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 15 Jan 2025.
- 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.
Said Hachimi-Idrissi, MD contact
2 sites 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 in people with Cardiac Arrest, run by University Hospital, Ghent at 2 sites in Belgium.
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: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 Maxim Vanwulpen, MD (09 332 21 11, maxim.vanwulpen@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivered ventilation frequency (time frame: 2 minutes). The study lists 2 primary outcomes in all. 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 15 Jan 2025.