NCT04459884

Multicenter Observational Study on Practice of Ventilation in Brain Injured Patients

Completed Last updated 25 March 2026

What this trial tests

trial testing mechanical ventilation in Mechanical Ventilation in 2,299 participants. Completed in 12 September 2024.

Timeline

23 August 2021

Primary endpoint
12 September 2024

12 September 2024

Quick facts

Lead sponsor	University of Milano Bicocca
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,299
Start date	23 August 2021
Primary completion	12 September 2024
Estimated completion	12 September 2024
Sites	1 location across Italy

Drugs / interventions tested

• mechanical ventilation

Conditions studied

• Mechanical Ventilation — all drugs for Mechanical Ventilation →
• Acute Brain Injury — all drugs for Acute Brain Injury →

Sponsor

University of Milano Bicocca

Who can join

18 and older, any sex, with Mechanical Ventilation or Acute Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale Several experimental and clinical studies have shown how brain injury can cause secondary lung injury. Lung injury could be due either to mechanical ventilation- often necessary in brain injured patients- or to inflammatory response that follows primary acute brain injury. The concept of 'Protective lung ventilation' has shown to reduce morbidity and mortality of intensive care unit (ICU) patients with acute respiratory distress syndrome (ARDS) but seems also to have a beneficial effect on patients with healthy lungs and in the perioperative settings. However, these recommendations often come into conflict with the management of patients affected by acute brain injury, in which permissive hypercapnia and increased intrathoracic pressure as consequence of protective ventilation strategies can be dangerous.

Study design This is an international multi-center prospective observational study.

Study population This study will include all consecutive brain injured patients (traumatic brain injury (TBI) or cerebrovascular) intubated and ventilated in ICU and observed for a 7-day period.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness Seen the observational design of the study, there is no patient burden. Collection of data from ICU and hospital charts and/or (electronic) medical records systems is of no risk to patients.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Utilization of mechanical power and associations with clinical outcomes in brain injured patients: a secondary analysis of the extubation strategies in neuro-intensive care unit patients and associations with outcome (ENIO) trial.
   Wahlster S, Sharma M, Taran S, Town JA, et al · · 2023 · cited 23× · PMID 37081474 · DOI 10.1186/s13054-023-04410-z
2. Ventilation practices in acute brain injured patients and association with outcomes: the VENTIBRAIN multicenter observational study.
   Robba C, Giardiello D, Almondo C, Asehnoune K, et al · · 2025 · cited 20× · PMID 39992441 · DOI 10.1007/s00134-025-07808-1
3. Multicentre observational study on practice of ventilation in brain injured patients: the VENTIBRAIN study protocol.
   Robba C, Citerio G, Taccone FS, Galimberti S, et al · · 2021 · cited 13× · PMID 34380722 · DOI 10.1136/bmjopen-2020-047100
4. Dynamic driving pressure and clinical outcomes in mechanically ventilated patients with acute brain injury: a secondary analysis of the VENTIBRAIN study<sup/>.
   Taran S, Citerio G, Taccone FS, Rezoagli E, et al · · 2026 · cited 2× · PMID 41537840 · DOI 10.1007/s00134-025-08241-0