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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01885507
First received: June 18, 2013
Last updated: February 19, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Brain-injury
Stroke
Subarachnoid Haemorrhage
Traumatic Brain Injury
Structural Coma
Other: Pass recommendations on ventilation factors and extubation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Mechanical ventilatory free days [ Time Frame: Day-90 ] [ Designated as safety issue: No ]
    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:
  • Mortality [ Time Frame: day-90 ] [ Designated as safety issue: No ]
  • In-ICU mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • ICU free days at day 90 [ Time Frame: day 90 ] [ Designated as safety issue: No ]
    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

  • Acute respiratory distress syndrome / acute lung injury [ Time Frame: day-90 ] [ Designated as safety issue: No ]
  • Hospital acquired pneumonia [ Time Frame: day-90 ] [ Designated as safety issue: No ]
  • Blood gaz [ Time Frame: day-5 ] [ Designated as safety issue: No ]
    PaO2 (arterial pressure of oxygen) and PaCO2 (arterial pressure of dioxide of carbon)

  • Intracranial pressure [ Time Frame: day-5 ] [ Designated as safety issue: No ]
  • Glasgow outcome scale [ Time Frame: day-90 ] [ Designated as safety issue: No ]
  • Extubation failure [ Time Frame: day-90 ] [ Designated as safety issue: No ]
  • Ventilatory setting [ Time Frame: day-5 ] [ Designated as safety issue: No ]
    Tidal volume and Positive end expiratory pressure


Enrollment: 560
Study Start Date: July 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Structural coma.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885507

Locations
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, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Karim Asehnoune, MD, PhD Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01885507     History of Changes
Other Study ID Numbers: RC13_0127
Study First Received: June 18, 2013
Last Updated: February 19, 2015
Health Authority: France: Institutional Ethical Committee

Additional relevant MeSH terms:
Brain Injuries
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Craniocerebral Trauma
Hemorrhage
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2015