Mechanical Ventilation in Brain-injured Patients

NCT01885507 — Completed, 560 participants, Nantes University Hospital

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

RegistryNCT01885507, acronym BI-VILI
StatusCompleted
Study typeObservational
Enrollment560 (Actual)
SponsorNantes University Hospital (Other)
ConditionsBrain-injury, Stroke, Subarachnoid Haemorrhage, Traumatic Brain Injury, Structural Coma
InterventionsPass recommendations on ventilation factors and extubation (Other)
Datesstart 2013-07-01, primary completion 2014-09-01, completion 2014-09-01, first posted 2013-06-25, last updated 2015-02-23
Locations22 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Brain-injury All trials for Stroke All trials of Pass recommendations on ventilation factors and extubation

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Control phase (before)Process of care and outcomes before the educational program
Training phase (after)Other: Pass recommendations on ventilation factors and extubationProcess 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
  • Pass recommendations on ventilation factors and extubation (Other): * 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

+Outcome measures

Primary outcomes

  • 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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (22)

FacilityCityCountryStatus
Angers University HospitalAngersFrance
Beaujon HospitalBeaujonFrance
Brest University HospitalBrestFrance
Caen University HospitalCaenFrance
Clermont-Ferrand University HospitalClermont-FerrandFrance
Henri Mondor University HospitalCréteilFrance
Grenoble University HospitalGrenobleFrance
Bicêtre University HospitalLe Kremlin-BicêtreFrance
Marseille University HospitalMarseilleFrance
Montpellier University HospitalMontpellierFrance
Nantes University HospitalNantesFrance
Nice University HospitalNiceFrance
Nimes University HospitalNîmesFrance
Georges Pompidou European HospitalParisFrance
Poitiers University HospitalPoitiersFrance
Rennes University HospitalRennesFrance
Rouen University HospitalRouenFrance
Nantes University HospitalSaint-HerblainFrance
Toulouse University Hospital - PurpanToulouseFrance
Toulouse University Hospital - RangueilToulouseFrance
Tours Univeristy Hospital - Neurosurgery ICUToursFrance
Tours University Hospital - Neurotrauma ICUToursFrance

+Publications

  • Results publication: 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. PMID 28315940

+Investigators