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Completed

NCT Number: NCT02235376

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

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

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Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

weaning trial of mechanical ventilation

Other

Primary outcomes

  1. Failure of extubation defined by the need of reintubation or the need for non-invasive ventilation

    Time frame: 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 outcomes

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

    Time frame: at ady 1

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

    Time frame: at day 1

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

    Time frame: at day 1

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

    Time frame: at day 1

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

    Time frame: at day 1

  6. - 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

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

    Time frame: at day 2

  8. Delay of extubation from intubation day (number of days)

    Time frame: at day 1

  9. Glasgow Outcome Score (GOS)

    Time frame: at 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: GODWEAN

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2014
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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