CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,299 enrolled
Drug / intervention
mechanical ventilationprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04459884
NCT04459884N/ACompleted

Multicenter Observational Study on Practice of Ventilation in Brain Injured Patients

University of Milano Bicocca·observational·Posted Jul 7, 2020·Updated Mar 25, 2026

In Brief

An observational study evaluating mechanical ventilation for Mechanical Ventilation and Acute Brain Injury. Completed, enrolled 2,299 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 7, 2020
Enrollment StartAug 23, 2021
Primary CompletionSep 12, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.0 years ago

Interventions

mechanical ventilationprocedure

mechanical ventilation \> 48h