Brain Injuries, AcuteBRAVENCT06367816
Brain Recovery With Automated VEntilation
An observational study of Brain Injuries, Acute and Respiration, Artificial, run by University of Genova at 1 site in Italy.
Trial summary
Thus far, the closed-loop ventilation mode INTELLiVENT-ASV has been extensively tested in various groups of critically ill patients, and has been shown to be effective and safe in various groups of ventilated patients, including those at risk of acute respiratory distress syndrome (ARDS), patients with ARDS, and… Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Brain Injuries, Acute, Respiration, Artificial, Automation
- What is being tested?
- INTELLiVENT and Conventional ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 11 Apr 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Invasively ventilated acute brain injury (ABI) patients admitted to the ICU of the Policlinico San Martino Hospital, Genova, Italy
Who may be able to join
- aged ≥ 18 years;
- intubated and receiving invasive ventilation for ABI;
- admitted to the Intensive Care Unit
Who cannot join
- receiving ventilation with a ventilator that does not allow INTELLiVENT-ASV
Trial locations and contacts
1 site in 1 country.
Italy1 site
UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino
Genova, GE, 16132
About this study
Official title: Effectiveness, Safety and Efficacy of Closed-Loop Ventilation in Acute Brain Injury-Patients
Thus far, the closed-loop ventilation mode INTELLiVENT-ASV has been extensively tested in various groups of critically ill patients, and has been shown to be effective and safe in various groups of ventilated patients, including those at risk of acute respiratory distress syndrome (ARDS), patients with ARDS, and patients with chronic obstructive pulmonary disease (COPD). Some of these studies included acute brain injury (ABI) patients, but the effectiveness, efficacy and safety of INTELLiVENT-ASV has never been thoroughly tested in these patients. The current study will investigate the effectiveness in providing both brain- and lung protective ventilation, the safety and the efficacy of a closed-loop ventilation mode (INTELLiVENT-ASV) in acute brain injury patients, using breath-by-breath data.
Read the detailed description
Rationale: Closed-loop ventilation has been proven effective in lung-protective ventilation but its effectiveness, safety and efficacy in providing both lung- and brain-protective ventilation in patients with acute brain injury has not been investigated.
Objective: To evaluate the effectiveness, efficacy and safety of INTELLiVENT-ASV with respect to brain- and lung-protective ventilation in ABI patients
Hypothesis: We hypothesize that INTELLiVENT-ASV is effective with regard to brain- and lung-protective ventilation (that is achieving brain- and lung- protective targets), efficacious (that is improving outcomes), and that INTELLiVENT-ASV is safe in invasively ventilated ABI patients.
Study design: Single-center, crossover trial.
Methods: In this prospective observational study, breath-by-breath ventilation data will be available from before and after the switch to closed-loop ventilation with INTELLiVENT-ASV, wherein the decision to switch is determined by the attending healthcare worker, i.e., not protocolized and only for clinical/organizational reasons. High granular data are collected both before and after this switch, limited to three hours for conventional and three hours for closed-loop ventilation. Neuromonitoring is part of current clinical practice and data will be collected only when available.
Study population: Invasively ventilated patients diagnosed with acute brain injury Methods: When the ventilator is switched upon the caregivers decision, data will be collected from three hours before the switch and three hours after the switch.
Study endpoints: The primary composite endpoint is the proportion of breaths and proportion of time within predefined zones of ventilation (based on VT and airway pressures, saturation of peripheral O2 (SpO2) and end-tidal CO2 (EtCO2).
- Conditions
- Brain Injuries, Acute, Respiration, Artificial, Automation
- Being tested
- INTELLiVENT, Conventional ventilation
- Medical subject headings
- Brain Injuries, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTELLiVENTProcedure or surgery
Closed-loop mode of ventilation
Conventional ventilationProcedure or surgery
Mode of ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of breaths in predefined zones of ventilation
Measured: 7 hours from baseline
Proportion of time in predefined zones of ventilation
Measured: 7 hours from baseline
Secondary outcomes (19)
Intracerebral changes assessed by multimodal neuromonitoring available
Measured: 7 hours from baseline
Changes on Electrical Impedence Tomography when available
Measured: 7 hours from baseline
Effectiveness in primary ABI patients vs non primary ABI patients
Measured: 7 hours from baseline
Episodes and time of high maximum airway pressure
Measured: 7 hours from baseline
Episodes and time of high respiratory rate
Measured: 7 hours from baseline
Incidence of severe hypoxemia
Measured: 7 hours from baseline
Incidence of severe hypercapnia
Measured: 7 hours from baseline
Discontinuation of ventilatory mode (yes or no)
Measured: 7 hours from baseline
Percentage of breaths in the predefined 'critical' ventilation zone
Measured: 7 hours from baseline
Incidence of pneumothorax
Measured: 8 hours from baseline
Efficacy on glascow coma scale
Measured: 7 hours from baseline
Duration of ventilation in survivors
Measured: 90 days
Ventilator free days
Measured: 90 days
Intensive care unit length of stay
Measured: 90 days
Hospital length of stay
Measured: 90 days
28-day mortality
Measured: 90 days
90-day mortality
Measured: 90 days
Number of alarms
Measured: 7 hours from baseline
Number of manual adjustments
Measured: 7 hours from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start11 Apr 2024
- Primary completion31 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Ball, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367816
- Sponsor's protocol ID
- 13509
- Acronym
- BRAVE
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goossen RL, Gavinelli S, Dragoni S, van Meenen DMP, Paulus F, Schultz MJ, Ball L, Patroniti NA, Robba C. Brain protective ventilation in acute brain injury patients with use of fully automated ventilation (BRAVE): A cross-over clinical trial. Eur J Anaesthesiol. 2026 Mar 1;43(3):235-244. doi: 10.1097/EJA.0000000000002253. Epub 2025 Aug 22.
PubMed 40855946
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Safety and Efficacy of Closed-Loop Ventilation in Acute Brain Injury-Patients
- ClinicalTrials.gov ID
- NCT06367816
- Acronym / sponsor ID
- BRAVE / 13509
- Conditions
- Brain Injuries, Acute, Respiration, Artificial, Automation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Apr 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.
Thus far, the closed-loop ventilation mode INTELLiVENT-ASV has been extensively tested in various groups of critically ill patients, and has been shown to be effective and safe in various groups of ventilated patients, including those at risk of acute respiratory distress syndrome (ARDS), patients with ARDS, and patients with chronic obstructive pulmonary disease (COPD). Some of these studies included acute brain injury (ABI) patients, but the effectiveness, efficacy and safety of INTELLiVENT-ASV has never been thoroughly tested in these patients. The current study will investigate the effectiveness in providing both brain- and lung protective ventilation, the safety and the efficacy of a closed-loop ventilation mode (INTELLiVENT-ASV) in acute brain injury patients, using breath-by-breath data.
Detailed description
Rationale: Closed-loop ventilation has been proven effective in lung-protective ventilation but its effectiveness, safety and efficacy in providing both lung- and brain-protective ventilation in patients with acute brain injury has not been investigated.
Objective: To evaluate the effectiveness, efficacy and safety of INTELLiVENT-ASV with respect to brain- and lung-protective ventilation in ABI patients
Hypothesis: We hypothesize that INTELLiVENT-ASV is effective with regard to brain- and lung-protective ventilation (that is achieving brain- and lung- protective targets), efficacious (that is improving outcomes), and that INTELLiVENT-ASV is safe in invasively ventilated ABI patients.
Study design: Single-center, crossover trial.
Methods: In this prospective observational study, breath-by-breath ventilation data will be available from before and after the switch to closed-loop ventilation with INTELLiVENT-ASV, wherein the decision to switch is determined by the attending healthcare worker, i.e., not protocolized and only for clinical/organizational reasons. High granular data are collected both before and after this switch, limited to three hours for conventional and three hours for closed-loop ventilation. Neuromonitoring is part of current clinical practice and data will be collected only when available.
Study population: Invasively ventilated patients diagnosed with acute brain injury Methods: When the ventilator is switched upon the caregivers decision, data will be collected from three hours before the switch and three hours after the switch.
Study endpoints: The primary composite endpoint is the proportion of breaths and proportion of time within predefined zones of ventilation (based on VT and airway pressures, saturation of peripheral O2 (SpO2) and end-tidal CO2 (EtCO2).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Invasively ventilated acute brain injury (ABI) patients admitted to the ICU of the Policlinico San Martino Hospital, Genova, Italy
Key inclusion criteria (3 listed)
- aged ≥ 18 years;
- intubated and receiving invasive ventilation for ABI;
- admitted to the Intensive Care Unit
Key exclusion criteria (1 listed)
- receiving ventilation with a ventilator that does not allow INTELLiVENT-ASV
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 |
|---|---|---|
| INTELLiVENTClosed-loop mode of ventilation | Procedure or surgery | – |
| Conventional ventilationMode of ventilation | Procedure or surgery | – |
Primary outcome
Proportion of breaths in predefined zones of ventilation
Time frame: 7 hours from baseline
Proportion of time in predefined zones of ventilation
Time frame: 7 hours from baseline
19 secondary outcomes
Intracerebral changes assessed by multimodal neuromonitoring available
Time frame: 7 hours from baseline
Changes on Electrical Impedence Tomography when available
Time frame: 7 hours from baseline
Effectiveness in primary ABI patients vs non primary ABI patients
Time frame: 7 hours from baseline
Episodes and time of high maximum airway pressure
Time frame: 7 hours from baseline
Episodes and time of high respiratory rate
Time frame: 7 hours from baseline
Incidence of severe hypoxemia
Time frame: 7 hours from baseline
Incidence of severe hypercapnia
Time frame: 7 hours from baseline
Discontinuation of ventilatory mode (yes or no)
Time frame: 7 hours from baseline
Percentage of breaths in the predefined 'critical' ventilation zone
Time frame: 7 hours from baseline
Incidence of pneumothorax
Time frame: 8 hours from baseline
Efficacy on glascow coma scale
Time frame: 7 hours from baseline
Duration of ventilation in survivors
Time frame: 90 days
Ventilator free days
Time frame: 90 days
Intensive care unit length of stay
Time frame: 90 days
Hospital length of stay
Time frame: 90 days
28-day mortality
Time frame: 90 days
90-day mortality
Time frame: 90 days
Number of alarms
Time frame: 7 hours from baseline
Number of manual adjustments
Time frame: 7 hours from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 40855946Goossen RL, Gavinelli S, Dragoni S, van Meenen DMP, Paulus F, Schultz MJ, Ball L, Patroniti NA, Robba C. Brain protective ventilation in acute brain injury patients with use of fully automated ventilation (BRAVE): A cross-over clinical trial. Eur J Anaesthesiol. 2026 Mar 1;43(3):235-244. doi: 10.1097/EJA.0000000000002253. Epub 2025 Aug 22.
- Individual participant dataSharing planned: No
Related trials for Brain Injuries, Acute
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Active, not recruitingObservational study
Psychoactive Drug Use and Acute Care Use After Trauma and Out-of-Hospital Cardiac Arrest
Wounds and Injuries, Out-of-Hospital Cardiac Arrest
Recruiting
Assessment of the Rehabilitative Effects of Curved-walking Training in Stroke, Parkinson and Orthopaedic Populations
Stroke, Acute, Parkinson Disease
Not yet recruitingPhase 3
Sovateltide for the Treatment of Acute Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruiting
Therapeutic Benefits of Pareidolia in Acute Traumatic Brain Injury Patients
Traumatic Brain Injuries
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Acute and Respiration, Artificial, run by University of Genova at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 10 Mar 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of breaths in predefined zones of ventilation (time frame: 7 hours from baseline). 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?
On the ClinicalTrials.gov record for NCT06367816, which also lists 1 linked publication.
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 10 Mar 2026.