protocolSection identificationModule nctId: NCT06367816, orgStudyIdInfo id: 13509, briefTitle: Brain Recovery With Automated VEntilation, acronym: BRAVE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Genova, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Brain Injuries, Acute, conditions: Respiration, Artificial, conditions: Automation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: INTELLiVENT, interventions name: Conventional ventilation, outcomesModule primaryOutcomes measure: Proportion of breaths in predefined zones of ventilation, primaryOutcomes measure: Proportion of time in predefined zones of ventilation, secondaryOutcomes measure: Intracerebral changes assessed by multimodal neuromonitoring available, secondaryOutcomes measure: Changes on Electrical Impedence Tomography when available, secondaryOutcomes measure: Effectiveness in primary ABI patients vs non primary ABI patients, secondaryOutcomes measure: Episodes and time of high maximum airway pressure, secondaryOutcomes measure: Episodes and time of high respiratory rate, secondaryOutcomes measure: Incidence of severe hypoxemia, secondaryOutcomes measure: Incidence of severe hypercapnia, secondaryOutcomes measure: Discontinuation of ventilatory mode (yes or no), secondaryOutcomes measure: Percentage of breaths in the predefined 'critical' ventilation zone, secondaryOutcomes measure: Incidence of pneumothorax, secondaryOutcomes measure: Efficacy on glascow coma scale, secondaryOutcomes measure: Duration of ventilation in survivors, secondaryOutcomes measure: Ventilator free days, secondaryOutcomes measure: Intensive care unit length of stay, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: 28-day mortality, secondaryOutcomes measure: 90-day mortality, secondaryOutcomes measure: Number of alarms, secondaryOutcomes measure: Number of manual adjustments, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino, status: RECRUITING, city: Genova, state: GE, zip: 16132, country: Italy, contacts name: Denise Battaglini, MD, PhD, role: CONTACT, phone: +39-0105554970, email: battaglini.denise@gmail.com, contacts name: Lorenzo Ball, MD, PhD, role: CONTACT, phone: +39-0105554970, email: lorenzo.ball@unige.it, geoPoint lat: 44.40478, lon: 8.94438, hasResults: False