An observational study in Brain Injuries, Acute, Respiration, Artificial and Automation, sponsored by University of Genova. Completed at 1 site in Italy. Open to participants aged 18 Years to 105 Years. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by University of Genova · Observational
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.
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).
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Genova is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Invasively ventilated acute brain injury (ABI) patients admitted to the ICU of the Policlinico San Martino Hospital, Genova, Italy
Exclusion Criteria:
- receiving ventilation with a ventilator that does not allow INTELLiVENT-ASV
Closed-loop mode of ventilation
Mode of ventilation
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
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
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Genova