Brain Recovery With Automated VEntilation

NCT06367816 | Completed

• 1 other identifier: 13509
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Acute; Respiration, Artificial; Automation

Outcome Measures

Primary Outcomes (2)

• Proportion of breaths in predefined zones of ventilation

  7 hours from baseline

• Proportion of time in predefined zones of ventilation

  7 hours from baseline

Secondary Outcomes (19)

• Intracerebral changes assessed by multimodal neuromonitoring available

  7 hours from baseline

• Changes on Electrical Impedence Tomography when available

  7 hours from baseline

• Effectiveness in primary ABI patients vs non primary ABI patients

  7 hours from baseline

• Episodes and time of high maximum airway pressure

  7 hours from baseline

• Episodes and time of high respiratory rate

  7 hours from baseline

Interventions

INTELLiVENT PROCEDURE

Closed-loop mode of ventilation

Conventional ventilation PROCEDURE

Mode of ventilation

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Genova: lead

Study Sites (1)

UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino

Genova, GE, 16132, Italy

Location

Related Publications (1)

• 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.

  PMID: 40855946 DERIVED

MeSH Terms

Conditions

Brain Injuries; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: April 11, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)