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Multicenter Observational Study on Practice of Ventilation in Brain Injured Patients

NCT04459884 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2299

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

  • Mechanical Ventilation
  • Acute Brain Injury

Interventions

PROCEDURE

mechanical ventilation

mechanical ventilation \> 48h

Sponsors & Collaborators

  • University of Milano Bicocca

    lead OTHER

Principal Investigators

  • Chiara Robba, MD · University of Milano Bicocca

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2024-09-12
Completion
2024-09-12

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04459884 on ClinicalTrials.gov