Clinical trial NCT01885507: Mechanical Ventilation in Brain-injured Patients
Official title: Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain-injury
Stroke
Subarachnoid Haemorrhage
Traumatic Brain Injury
Structural Coma
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Structural coma.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mechanical ventilatory free days
timeFrame: Day-90
Secondary outcomes:
measure: Mortality
timeFrame: day-90
measure: In-ICU mortality
timeFrame: 90 days
measure: Duration of mechanical ventilation
timeFrame: 90 days
measure: ICU free days at day 90
timeFrame: day 90
measure: Acute respiratory distress syndrome / acute lung injury
timeFrame: day-90
measure: Hospital acquired pneumonia
timeFrame: day-90
measure: Blood gaz
timeFrame: day-5
measure: Intracranial pressure
timeFrame: day-5
measure: Glasgow outcome scale
timeFrame: day-90
measure: Extubation failure
timeFrame: day-90
measure: Ventilatory setting
timeFrame: day-5
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Beaujon
country: France
facility: Beaujon Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Créteil
country: France
facility: Henri Mondor University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Le Kremlin Bicêtre
country: France
facility: Bicêtre University Hospital
city: Marseille
country: France
facility: Marseille University Hospital
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Nice
country: France
facility: Nice University Hospital
city: Nime
country: France
facility: Nimes University Hospital
city: Paris
country: France
facility: Georges Pompidou European Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Saint Herblain
country: France
facility: Nantes University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital - Purpan
city: Toulouse
country: France
facility: Toulouse University Hospital - Rangueil
city: Tours
country: France
facility: Tours Univeristy Hospital - Neurosurgery ICU
city: Tours
country: France
facility: Tours University Hospital - Neurotrauma ICU
Study officials:
affiliation: Nantes University Hospital
name: Karim Asehnoune, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.