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

Completed

• Conditions: Brain Injury

• Registration Number: NCT02235376
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-10
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) 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
Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU	at ady 1
Glasgow Outcome Score (GOS)	at 6 months
Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU	at day 1
cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay	at day 1
Delay of extubation from intubation day (number of days)	at day 1
- Cause of extubation failure before 48 hours (respiratory, hemodynamic, aspiration, ...)	at day 2
- 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

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France