Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
560 participants
OBSERVATIONAL
2013-07-31
2014-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control phase (before)
Process of care and outcomes before the educational program
No interventions assigned to this group
Training phase (after)
Process of care and outcomes after the educational program which recommends:
* the use of tidal volume \< 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water)
* extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cough
Pass recommendations on ventilation factors and extubation
* the use of tidal volume \< 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water)
* extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cough
Interventions
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Pass recommendations on ventilation factors and extubation
* the use of tidal volume \< 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water)
* extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cough
Eligibility Criteria
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Inclusion Criteria
* 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
* death in the first 24 hours
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Karim Asehnoune, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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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
Nîmes, , 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, , France
Countries
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References
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Asehnoune K, Mrozek S, Perrigault PF, Seguin P, Dahyot-Fizelier C, Lasocki S, Pujol A, Martin M, Chabanne R, Muller L, Hanouz JL, Hammad E, Rozec B, Kerforne T, Ichai C, Cinotti R, Geeraerts T, Elaroussi D, Pelosi P, Jaber S, Dalichampt M, Feuillet F, Sebille V, Roquilly A; BI-VILI study group. A multi-faceted strategy to reduce ventilation-associated mortality in brain-injured patients. The BI-VILI project: a nationwide quality improvement project. Intensive Care Med. 2017 Jul;43(7):957-970. doi: 10.1007/s00134-017-4764-6. Epub 2017 Mar 18.
Other Identifiers
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RC13_0127
Identifier Type: -
Identifier Source: org_study_id
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