Mechanical Ventilation in Brain-injured Patients

Stroke Clinical Trial

— BI-VILI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885507
• Other study ID #: RC13_0127
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: February 19, 2015
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Brain-injury
• Stroke
• Structural Coma
• Subarachnoid Haemorrhage
• Subarachnoid Hemorrhage
• Traumatic Brain Injury

Intervention

Other:
• Pass recommendations on ventilation factors and extubation
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

Locations

Country	Name	City	State
France	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	Nime
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

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mortality		day-90	No
Secondary	In-ICU mortality		90 days	No
Secondary	Duration of mechanical ventilation		90 days	No
Secondary	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	No
Secondary	Acute respiratory distress syndrome / acute lung injury		day-90	No
Secondary	Hospital acquired pneumonia		day-90	No
Secondary	Blood gaz	PaO2 (arterial pressure of oxygen) and PaCO2 (arterial pressure of dioxide of carbon)	day-5	No
Secondary	Intracranial pressure		day-5	No
Secondary	Glasgow outcome scale		day-90	No
Secondary	Extubation failure		day-90	No
Secondary	Ventilatory setting	Tidal volume and Positive end expiratory pressure	day-5	No