Brain Injury
Conditions
Keywords
Critical Care, Brain injured patients, Mechanical Ventilation, Weaning, Extubation, Prognostic score, Clinical examination
Brief summary
Identification of criteria associated with extubation failure of brain injured patients. Elaboration of a prognostic score of extubation failure of brain injured patients.
Detailed description
Prospective clinical study in ICU with brain injured ventilated patients eligible to extubation. Identification of clinical and biological criteria associated with failure of extubation. Elaboration of a prognostic score of extubation failure of brain injured patients, based on criteria previously identified with multivariate analysis. Failure of extubation is defined by the need of re-intubation or the need for non-invasive ventilation within 48 hours or more after extubation.
Interventions
OTHERweaning trial of mechanical ventilation
Sponsors
University Hospital, Clermont-Ferrand
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult brain injured patients ventilated eligible to discontinuation of mechanical ventilation * Stable respiratory and hemodynamic conditions * Ventilated patients for more than 48 hours * Adequate gaseous exchange (SpO2 ≥ 92% and respiratory rate ≤ 35/min, FiO2 ≤ 40%, positive end-expiratory pressure ≤ 5 cmH2O, pressure support ≤ 8 cmH2O, tidal volume ≥ 7mL/kg * Therapeutic extubation
Exclusion criteria
* • Status epilepticus * Cerebrospinal infection * Patients under 15 years old * Mechanical ventilation of \< 48 h * Spinal cord injury * Withdrawal of life support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation | at day 2 | \- Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation within 48 hours or during ICU stay |
Secondary
| Measure | Time frame |
|---|---|
| Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU | at day 1 |
| Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU | at day 1 |
| Complete neurological examination (Glasgow score, Coma Recovery Scale, FOUR score, cough, brain stem reflexes) just before extubation | at day 1 |
| cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay | at day 1 |
| Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU | at ady 1 |
| - Cause of extubation failure before 48 hours (respiratory, hemodynamic, aspiration, ...) | at day 2 |
| Delay of extubation from intubation day (number of days) | at day 1 |
| Glasgow Outcome Score (GOS) | at 6 months |
| - Pulmonary examination (arterial gasometry, ventilatory parameters: mode, frequency, positive end expiratory pressure, inspiratory pressure, tidal volume, minute ventilation, oxygen level) just before extubation | at day 1 |
Countries
France
Outcome results
None listed