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CompletedNCT02235376GODWEANUpdated Oct 15, 2015

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

An observational study in Brain Injury, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2015-10-15.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
140
Ages
15 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Brain Injury

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Keywords

  • Critical Care
  • Brain injured patients
  • Mechanical Ventilation
  • Weaning
  • Extubation
  • Prognostic score
  • Clinical examination
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 140 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

brain injured patients

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

Exclusion Criteria:

    • Status epilepticus

      • Cerebrospinal infection
      • Patients under 15 years old
      • Mechanical ventilation of \< 48 h
      • Spinal cord injury
      • Withdrawal of life support
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Study design

Time perspective
Prospective
Enrollment
140 participants (actual)
Patient registry
No

Groups and cohorts

  • critical care

    Other: weaning trial of mechanical ventilation

Interventions

  • Otherweaning trial of mechanical ventilation
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What researchers measure

Primary outcomes

  1. 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

  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

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Study locations

1 site
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, 63003, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02235376
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Sep 10, 2014
Start date
Jun 2013
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Oct 15, 2015

Study contacts

Russell CHABANNE
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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