Mechanical Ventilation in Brain-injured Patients

Last updated: February 19, 2015
Sponsor: Nantes University Hospital
Overall Status: Completed

Phase

N/A

Condition

Stroke

Traumatic Brain Injury

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT01885507
RC13_0127
  • Ages > 18
  • All Genders

Study Summary

Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic approach to extubation may decrease the rate of extubation failure and enhance outcomes of brain-injured patients.

We hypothesized that medical education and implementation of an evidence-base care bundle associating protective ventilation and systemic approach to extubation can reduce the duration of mechanical ventilation in brain-injured patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (traumatic brain-injured, subarachnoid hemorrhage, stroke or other)

  • Brain injury (Glasgow Coma Scale ≤ 12 associated with at least one anomaly related toan acute process on head tomographic tomodensitometry

  • mechanical ventilation for more than 24 hours

Exclusion

Exclusion Criteria:

  • early decision to withdraw care (taken in the first 24 hours in ICU),

  • death in the first 24 hours

Study Design

Total Participants: 560
Study Start date:
July 01, 2013
Estimated Completion Date:
September 30, 2014

Study Description

A before/after study design will be used. The before period (control phase) will consisted of all consecutive patients with severe brain-injury who were admitted to the participating ICUs.

During the interphase, all physicians, residents, physiotherapists and nurses will receive a formal training for the processes and procedures related to the 2 point bundle: protective ventilation and systematic approach to extubation (according to recommendation for the use of tidal volume < 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water) and extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cought).

The after period consisted of all consecutive severe brain-injured patients admitted to the participating ICUs after the formal training.

Connect with a study center

  • Angers University Hospital

    Angers,
    France

    Site Not Available

  • Beaujon Hospital

    Beaujon,
    France

    Site Not Available

  • Brest University Hospital

    Brest,
    France

    Site Not Available

  • Caen University Hospital

    Caen,
    France

    Site Not Available

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand,
    France

    Site Not Available

  • Henri Mondor University Hospital

    Créteil,
    France

    Site Not Available

  • Grenoble University Hospital

    Grenoble,
    France

    Site Not Available

  • Bicêtre University Hospital

    Le Kremlin Bicêtre,
    France

    Site Not Available

  • Lyon University Hospital

    Lyon,
    France

    Site Not Available

  • Marseille University Hospital

    Marseille,
    France

    Site Not Available

  • Montpellier University Hospital

    Montpellier,
    France

    Site Not Available

  • Nancy University Hospital

    Nancy,
    France

    Site Not Available

  • Nantes University Hospital

    Nantes,
    France

    Site Not Available

  • Nice University Hospital

    Nice,
    France

    Site Not Available

  • Nimes University Hospital

    Nime,
    France

    Site Not Available

  • Nimes University Hospital

    Nimes,
    France

    Site Not Available

  • Georges Pompidou European Hospital

    Paris,
    France

    Site Not Available

  • Georges Pompidou European Hospital

    Pars,
    France

    Site Not Available

  • Poitiers University Hospital

    Poitiers,
    France

    Site Not Available

  • Rennes University Hospital

    Rennes,
    France

    Site Not Available

  • Rouen University Hospital

    Rouen,
    France

    Site Not Available

  • Nantes University Hospital

    Saint Herblain,
    France

    Site Not Available

  • Toulouse University Hospital - Purpan

    Toulouse,
    France

    Site Not Available

  • Toulouse University Hospital - Rangueil

    Toulouse,
    France

    Site Not Available

  • Tours Univeristy Hospital - Neurosurgery ICU

    Tours,
    France

    Site Not Available

  • Tours University Hospital - Neurotrauma ICU

    Tours,
    France

    Site Not Available

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