Mechanical Ventilation in Brain-injured Patients

Completed

• Conditions: Stroke; Subarachnoid Haemorrhage; Structural Coma; Brain-injury; Traumatic Brain Injury
• Interventions: Other: Pass recommendations on ventilation factors and extubation

• Registration Number: NCT01885507
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-25
• Study Start: 2013-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training phase (after)	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

Primary Outcome Measures

Name	Time	Method
Mechanical ventilatory free days	Day-90	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

Secondary Outcome Measures

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

Trial Locations

Locations (21)

Brest University Hospital; 🇫🇷 Brest, France

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France

Angers University Hospital; 🇫🇷 Angers, France

Beaujon Hospital; 🇫🇷 Beaujon, France

Caen University Hospital; 🇫🇷 Caen, 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; 🇫🇷 Saint Herblain, France

Nice University Hospital; 🇫🇷 Nice, France

Nimes University Hospital; 🇫🇷 Nime, France

Georges Pompidou European Hospital; 🇫🇷 Paris, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

Rennes University Hospital; 🇫🇷 Rennes, France

Toulouse University Hospital - Rangueil; 🇫🇷 Toulouse, France

Rouen University Hospital; 🇫🇷 Rouen, France

Toulouse University Hospital - Purpan; 🇫🇷 Toulouse, France

Tours Univeristy Hospital - Neurosurgery ICU; 🇫🇷 Tours, France

Tours University Hospital - Neurotrauma ICU; 🇫🇷 Tours, France