Clinical trial NCT02235376: Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.
Official title: Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury
Keywords: Critical Care
Brain injured patients
Mechanical Ventilation
Weaning
Extubation
Prognostic score
Clinical examination
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 140
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: brain injured patients

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.

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

Primary outcomes:
measure: Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation
timeFrame: at day 2
Secondary outcomes:
measure: Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU
timeFrame: at ady 1
measure: Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU
timeFrame: at day 1
measure: Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU
timeFrame: at day 1
measure: Complete neurological examination (Glasgow score, Coma Recovery Scale, FOUR score, cough, brain stem reflexes) just before extubation
timeFrame: at day 1
measure: cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay
timeFrame: at day 1
measure: - Pulmonary examination (arterial gasometry, ventilatory parameters: mode, frequency, positive end expiratory pressure, inspiratory pressure, tidal volume, minute ventilation, oxygen level) just before extubation
timeFrame: at day 1
measure: - Cause of extubation failure before 48 hours (respiratory, hemodynamic, aspiration, ...)
timeFrame: at day 2
measure: Delay of extubation from intubation day (number of days)
timeFrame: at day 1
measure: Glasgow Outcome Score (GOS)
timeFrame: at 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Russell CHABANNE
role: PRINCIPAL_INVESTIGATOR
References: