Mechanical Ventilation in Brain-injured Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project

Conditions
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Brain-injury, Stroke, Subarachnoid Haemorrhage, Traumatic Brain Injury, Structural Coma

Intervention / Treatment
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* Other: Pass recommendations on ventilation factors and extubation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control phase (before)<br>Process of care and outcomes before the educational program | |
| Training phase (after)<br>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 | Other: Pass recommendations on ventilation factors and extubation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | day-90 | 
| In-ICU mortality |  | 90 days | 
| Duration of mechanical ventilation |  | 90 days | 
| 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 | 
| Acute respiratory distress syndrome / acute lung injury |  | day-90 | 
| Hospital acquired pneumonia |  | day-90 | 
| Blood gaz | PaO2 (arterial pressure of oxygen) and PaCO2 (arterial pressure of dioxide of carbon) | day-5 | 
| Intracranial pressure |  | day-5 | 
| Glasgow outcome scale |  | day-90 | 
| Extubation failure |  | day-90 | 
| Ventilatory setting | Tidal volume and Positive end expiratory pressure | day-5 |