Clinical trial NCT06367816: Brain Recovery With Automated VEntilation
Official title: Effectiveness, Safety and Efficacy of Closed-Loop Ventilation in Acute Brain Injury-Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Injuries, Acute
Respiration, Artificial
Automation
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Invasively ventilated acute brain injury (ABI) patients admitted to the ICU of the Policlinico San Martino Hospital, Genova, Italy

Brief 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 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).

Eligibility criteria: Inclusion Criteria:

* aged ≥ 18 years;
* intubated and receiving invasive ventilation for ABI;
* admitted to the Intensive Care Unit

Exclusion Criteria:

- receiving ventilation with a ventilator that does not allow INTELLiVENT-ASV

Primary outcomes:
measure: Proportion of breaths in predefined zones of ventilation
timeFrame: 7 hours from baseline
measure: Proportion of time in predefined zones of ventilation
timeFrame: 7 hours from baseline
Secondary outcomes:
measure: Intracerebral changes assessed by multimodal neuromonitoring available
timeFrame: 7 hours from baseline
measure: Changes on Electrical Impedence Tomography when available
timeFrame: 7 hours from baseline
measure: Effectiveness in primary ABI patients vs non primary ABI patients
timeFrame: 7 hours from baseline
measure: Episodes and time of high maximum airway pressure
timeFrame: 7 hours from baseline
measure: Episodes and time of high respiratory rate
timeFrame: 7 hours from baseline
measure: Incidence of severe hypoxemia
timeFrame: 7 hours from baseline
measure: Incidence of severe hypercapnia
timeFrame: 7 hours from baseline
measure: Discontinuation of ventilatory mode (yes or no)
timeFrame: 7 hours from baseline
measure: Percentage of breaths in the predefined 'critical' ventilation zone
timeFrame: 7 hours from baseline
measure: Incidence of pneumothorax
timeFrame: 8 hours from baseline
measure: Efficacy on glascow coma scale
timeFrame: 7 hours from baseline
measure: Duration of ventilation in survivors
timeFrame: 90 days
measure: Ventilator free days
timeFrame: 90 days
measure: Intensive care unit length of stay
timeFrame: 90 days
measure: Hospital length of stay
timeFrame: 90 days
measure: 28-day mortality
timeFrame: 90 days
measure: 90-day mortality
timeFrame: 90 days
measure: Number of alarms
timeFrame: 7 hours from baseline
measure: Number of manual adjustments
timeFrame: 7 hours from baseline
Other outcomes:
Locations:
city: Genova
country: Italy
facility: UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino
state: GE
Study officials:
References: