Mechanical Ventilation in Brain-injured Patients
BI-VILI
Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project
1 other identifier
observational
560
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2013
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2013
CompletedFirst Posted
Study publicly available on registry
June 25, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 23, 2015
January 1, 2015
1.2 years
June 18, 2013
February 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (11)
Mortality
day-90
In-ICU mortality
90 days
Duration of mechanical ventilation
90 days
ICU free days at day 90
day 90
Acute respiratory distress syndrome / acute lung injury
day-90
- +6 more secondary outcomes
Study Arms (2)
Control phase (before)
Process of care and outcomes before the educational program
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
Interventions
* 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
Structural coma.
You may qualify if:
- 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
You may not qualify if:
- early decision to withdraw care (taken in the first 24 hours in ICU),
- death in the first 24 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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
Related Publications (1)
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.
PMID: 28315940DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karim Asehnoune, MD, PhD
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2013
First Posted
June 25, 2013
Study Start
July 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
February 23, 2015
Record last verified: 2015-01