Mechanical Ventilation in Brain-injured Patients (BI-VILI)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Traumatic Brain Injury; Subarachnoid Haemorrhage; Brain-injury; Structural Coma
• Intervention / Treatment: Other: Pass recommendations on ventilation factors and extubation

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 Type: Observational
• Enrollment (Actual): 560

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Angers University Hospital
  • Beaujon, France
    • Beaujon hospital
  • Brest, France
    • Brest university hospital
  • Caen, France
    • CAEN university Hospital
  • Clermont-Ferrand, France
    • Clermont-Ferrand University Hospital
  • Créteil, France
    • Henri Mondor University Hospital
  • Grenoble, France
    • Grenoble University Hospital
  • Le Kremlin Bicêtre, France
    • Bicêtre University Hospital
  • Marseille, France
    • Marseille University Hospital
  • Montpellier, France
    • Montpellier University Hospital
  • Nantes, France
    • Nantes University Hospital
  • Nice, France
    • Nice university hospital
  • Nime, France
    • Nîmes University Hospital
  • Paris, France
    • Georges Pompidou European Hospital
  • Poitiers, France
    • Poitiers university hospital
  • Rennes, France
    • Rennes university hospital
  • Rouen, France
    • Rouen university hospital
  • Saint Herblain, France
    • Nantes University Hospital
  • Toulouse, France
    • Toulouse University Hospital - Purpan
  • Toulouse, France
    • Toulouse University Hospital - Rangueil
  • Tours, France
    • Tours Univeristy Hospital - Neurosurgery ICU
  • Tours, France
    • Tours University Hospital - Neurotrauma ICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Structural coma.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control phase (before); Process of care and outcomes before the educational program
Training phase (after); 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; 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

What is the study measuring?

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
Duration of mechanical ventilation		90 days
Mortality		day-90
In-ICU mortality		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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Karim Asehnoune, MD, PhD, Nantes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: June 18, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Estimate): February 23, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Subarachnoid Hemorrhage
• Other Study ID Numbers: RC13_0127