Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.

Study Overview
=================
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.

Official Title
-----------------
Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.

Conditions
-----------------
Brain Injury

Intervention / Treatment
-----------------
* Other: weaning trial of mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| critical care<br> | Other: weaning trial of mechanical ventilation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation | - Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation within 48 hours or during ICU stay | at day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU |  | at ady 1 | 
| 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 | 
| - 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 | 
| - 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical Care, Brain injured patients, Mechanical Ventilation, Weaning, Extubation, Prognostic score, Clinical examination