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

University Hospital, Clermont-Ferrand140 enrolled

Overview

Identification of criteria associated with extubation failure of brain injured patients. Elaboration of a prognostic score of extubation failure of brain injured patients.

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.

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Brain Injury

Interventions

weaning trial of mechanical ventilationOTHER

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

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

Time frame: at day 2

Secondary Outcomes

Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU

Time frame: at ady 1

Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU

Time frame: at day 1

Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU

Time frame: at day 1

Complete neurological examination (Glasgow score, Coma Recovery Scale, FOUR score, cough, brain stem reflexes) just before extubation

Time frame: at day 1

cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay

Time frame: 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

Time frame: at day 1

- Cause of extubation failure before 48 hours (respiratory, hemodynamic, aspiration, ...)

Time frame: at day 2

Delay of extubation from intubation day (number of days)

Time frame: at day 1

Data from ClinicalTrials.gov

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