Stroke Clinical Trial
— BI-VILIOfficial title:
Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project
Verified date | January 2015 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Institutional Ethical Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 560 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 to an acute process on head tomographic tomodensitometry - mechanical ventilation for more than 24 hours Exclusion Criteria: - early decision to withdraw care (taken in the first 24 hours in ICU), - death in the first 24 hours |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Angers University Hospital | Angers | |
France | Beaujon Hospital | Beaujon | |
France | Brest University Hospital | Brest | |
France | Caen University Hospital | Caen | |
France | Clermont-Ferrand University Hospital | Clermont-Ferrand | |
France | Henri Mondor University Hospital | Créteil | |
France | Grenoble University Hospital | Grenoble | |
France | Bicêtre University Hospital | Le Kremlin Bicêtre | |
France | Marseille University Hospital | Marseille | |
France | Montpellier University Hospital | Montpellier | |
France | Nantes University Hospital | Nantes | |
France | Nice University Hospital | Nice | |
France | Nimes University Hospital | Nime | |
France | Georges Pompidou European Hospital | Paris | |
France | Poitiers University Hospital | Poitiers | |
France | Rennes University Hospital | Rennes | |
France | Rouen University Hospital | Rouen | |
France | Nantes University Hospital | Saint Herblain | |
France | Toulouse University Hospital - Purpan | Toulouse | |
France | Toulouse University Hospital - Rangueil | Toulouse | |
France | Tours Univeristy Hospital - Neurosurgery ICU | Tours | |
France | Tours University Hospital - Neurotrauma ICU | Tours |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mechanical ventilatory free days | The number of ventilator-free days was defined as the number of days from day 1 to day 90 on which a patient breaths spontaneously and is alive | Day-90 | No |
Secondary | Mortality | day-90 | No | |
Secondary | In-ICU mortality | 90 days | No | |
Secondary | Duration of mechanical ventilation | 90 days | No | |
Secondary | ICU free days at day 90 | The number of ICU free days was defined as the number of days from day 1 to on which a patient is alive and not hospitalized in ICU | day 90 | No |
Secondary | Acute respiratory distress syndrome / acute lung injury | day-90 | No | |
Secondary | Hospital acquired pneumonia | day-90 | No | |
Secondary | Blood gaz | PaO2 (arterial pressure of oxygen) and PaCO2 (arterial pressure of dioxide of carbon) | day-5 | No |
Secondary | Intracranial pressure | day-5 | No | |
Secondary | Glasgow outcome scale | day-90 | No | |
Secondary | Extubation failure | day-90 | No | |
Secondary | Ventilatory setting | Tidal volume and Positive end expiratory pressure | day-5 | No |
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