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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01885507
First received: June 18, 2013
Last updated: August 8, 2013
Last verified: August 2013
  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
Brain-injury
Stroke
Subarachnoid Haemorrhage
Traumatic Brain Injury
Structural Coma

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


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

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

Contacts
Contact: Antoine Roquilly, MD 3240083005 antoine.roquilly@chu-nantes.Fr

Locations
France
Angers University Hospital Recruiting
Angers, France
Contact: Sigismond Lasocki, MD, PhD         
Principal Investigator: Sigismond Lasocki, MD, PhD         
Beaujon Hospital Not yet recruiting
Beaujon, France
Contact: Catherine Paugam, PhD, MD         
Principal Investigator: Catherine Paugam, MD, PhD         
Brest University Hospital Recruiting
Brest, France
Contact: Pascale Le Maguet, MD         
Principal Investigator: Pascale Le Maguet, MD         
Caen University Hospital Not yet recruiting
Caen, France
Contact: Jean Luc Hanouz, MD,PhD         
Principal Investigator: Jean Luc Hanouz         
Sub-Investigator: Guillaume Zamparini, MD,PhD         
Clermont-Ferrand University Hospital Recruiting
Clermont-Ferrand, France
Contact: Jean-Michel Constantin, MD, PhD         
Principal Investigator: Jean-Michel Constantin, MD, PhD         
Sub-Investigator: Russel Chabanne         
Henri Mondor University Hospital Recruiting
Créteil, France
Contact: Fabrice Cook, MD         
Principal Investigator: Fabrice Cook, MD         
Sub-Investigator: Matthieu Martin         
Grenoble University Hospital Not yet recruiting
Grenoble, France
Contact: Jean-François Payen, MD, PhD         
Principal Investigator: Jean-François Payen, MD, PhD         
Bicêtre University Hospital Not yet recruiting
Le Kremlin Bicêtre, France
Contact: Jacques Duranteau, MD, PhD         
Principal Investigator: Jacques Duranteau, MD, PhD         
Marseille University Hospital Recruiting
Marseille, France
Contact: Marc Leone, MD,PhD         
Principal Investigator: Marc Leone, MD,PhD         
Sub-Investigator: Emmanuelle Hammad, MD         
Montpellier University Hospital Recruiting
Montpellier, France
Contact: Pierre Francois Perrigault, MD         
Principal Investigator: Pierre Francois Perrigault, MD         
Nantes University Hospital Recruiting
Nantes, France
Contact: Karim Asehnoune, MD,PhD         
Principal Investigator: Karim Asehnoune, MD,PhD         
Nice University Hospital Recruiting
Nice, France
Contact: Carole Ichai, MD, PhD         
Principal Investigator: Carole Ichai, MD, PhD         
Nimes University Hospital Recruiting
Nime, France
Contact: Laurent Muller, MD         
Principal Investigator: Laurent Muller, MD         
Georges Pompidou European Hospital Recruiting
Pars, France
Contact: Didier Journois, MD, PhD         
Principal Investigator: Didier Journois, MD, PhD         
Poitiers University Hospital Recruiting
Poitiers, France
Contact: Olivier Mimoz, MD, PhD         
Principal Investigator: Olivier Mimoz, MD, PhD         
Sub-Investigator: Claire Dahyot, MD         
Sub-Investigator: Claire Pichot         
Rennes University Hospital Recruiting
Rennes, France
Contact: Yannick Malledant, MD, PhD         
Principal Investigator: Yannick Malledant, MD, PhD         
Sub-Investigator: Philippe Seguin, MD, PhD         
Rouen University Hospital Recruiting
Rouen, France
Contact: Benoit Veber, MD,PhD         
Principal Investigator: Benoit Veber, PD,PhD         
Nantes University Hospital Recruiting
Saint Herblain, France
Contact: Bertrand Rozec, MD         
Principal Investigator: Bertrand Rozec, MD,PhD         
Toulouse University Hospital - Purpan Recruiting
Toulouse, France
Contact: Thomas GEERRAERTS, MD,PhD         
Principal Investigator: Thomas GEERRAERTS         
Principal Investigator: Fouad Marhar, MD         
Toulouse University Hospital - Rangueil Not yet recruiting
Toulouse, France
Contact: Segolene Mrozek, MD         
Principal Investigator: Segolene Mrozek, MD         
Tours Univeristy Hospital - Neurosurgery ICU Recruiting
Tours, France
Contact: Martine Ferrandiere, MD         
Principal Investigator: Marc Laffon, MD         
Sub-Investigator: Djilali Elaroussi, MD         
Tours University Hospital - Neurotrauma ICU Not yet recruiting
Tours, France
Contact: Damien Bresson, MD         
Principal Investigator: Damien Bresson, MD         
Sponsors and Collaborators
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: August 8, 2013
Health Authority: France: Institutional Ethical Committee

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

ClinicalTrials.gov processed this record on October 21, 2014