Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project
| Registry | NCT01885507, acronym BI-VILI |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 560 (Actual) |
| Sponsor | Nantes University Hospital (Other) |
| Conditions | Brain-injury, Stroke, Subarachnoid Haemorrhage, Traumatic Brain Injury, Structural Coma |
| Interventions | Pass recommendations on ventilation factors and extubation (Other) |
| Dates | start 2013-07-01, primary completion 2014-09-01, completion 2014-09-01, first posted 2013-06-25, last updated 2015-02-23 |
| Locations | 22 sites in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Brain-injury All trials for Stroke All trials of Pass recommendations on ventilation factors and extubation
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control phase (before) | Process of care and outcomes before the educational program | ||
| Training phase (after) | Other: Pass recommendations on ventilation factors and extubation | 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 |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |