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

Brain Injury Clinical Trial

— GODWEAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235376
• Other study ID #: CHU-0201
• Status: Completed
• Phase: N/A
• First received: July 28, 2014
• Last updated: October 13, 2015
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injury

Intervention

Other:
• weaning trial of mechanical ventilation

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Severity scores (SAPS II, SOFA, GCS…) ) at patient admission in ICU		at ady 1	No
Secondary	Cause of brain injury (traumatic, ischemic, hemorrhagic or post-operative) at patient admission in ICU		at day 1	No
Secondary	Localisation of brain injury (hemispheric, supra- or sub-tentorial) at patient admission in ICU		at day 1	No
Secondary	Complete neurological examination (Glasgow score, Coma Recovery Scale, FOUR score, cough, brain stem reflexes) just before extubation		at day 1	No
Secondary	cardiologic history (cardiac insufficiency or ischemic cardiomyopathy) during ICU stay		at day 1	No
Secondary	- 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	No
Secondary	- Cause of extubation failure before 48 hours (respiratory, hemodynamic, aspiration, ...)		at day 2	No
Secondary	Delay of extubation from intubation day (number of days)		at day 1	No
Secondary	Glasgow Outcome Score (GOS)		at 6 months	No