Brain Recovery With Automated VEntilation

Respiration, Artificial Clinical Trial

— BRAVE  

Official title:

Effectiveness, Safety and Efficacy of Closed-Loop Ventilation in Acute Brain Injury-Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367816
• Other study ID #: 13509
• Status: Recruiting
• Start date: April 11, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Genova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Automation
• Brain Injuries
• Brain Injuries, Acute
• Respiration, Artificial

Intervention

Procedure:
• INTELLiVENT
Closed-loop mode of ventilation
• Conventional ventilation
Mode of ventilation

Locations

Country	Name	City	State
Italy	UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino	Genova	GE

Sponsors (1)

Lead Sponsor	Collaborator
University of Genova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of breaths in predefined zones of ventilation		7 hours from baseline
Primary	Proportion of time in predefined zones of ventilation		7 hours from baseline
Secondary	Intracerebral changes assessed by multimodal neuromonitoring available		7 hours from baseline
Secondary	Changes on Electrical Impedence Tomography when available		7 hours from baseline
Secondary	Effectiveness in primary ABI patients vs non primary ABI patients		7 hours from baseline
Secondary	Episodes and time of high maximum airway pressure		7 hours from baseline
Secondary	Episodes and time of high respiratory rate		7 hours from baseline
Secondary	Incidence of severe hypoxemia		7 hours from baseline
Secondary	Incidence of severe hypercapnia		7 hours from baseline
Secondary	Discontinuation of ventilatory mode (yes or no)		7 hours from baseline
Secondary	Percentage of breaths in the predefined 'critical' ventilation zone		7 hours from baseline
Secondary	Incidence of pneumothorax		8 hours from baseline
Secondary	Efficacy on glascow coma scale		7 hours from baseline
Secondary	Duration of ventilation in survivors		90 days
Secondary	Ventilator free days		90 days
Secondary	Intensive care unit length of stay		90 days
Secondary	Hospital length of stay		90 days
Secondary	28-day mortality		90 days
Secondary	90-day mortality		90 days
Secondary	Number of alarms		7 hours from baseline
Secondary	Number of manual adjustments		7 hours from baseline