Brain-injured Patients Extubation Readiness Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Brain Injury
- Airway Control
- Altered Level of Consciousness
- Mechanical Ventilation
- Mechanical Ventilator Weaning
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Stepped wedge, cluster randomised controlled designMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
Severe brain-injured patients need mechanical ventilation with tracheal intubation. After treatment of the acute neurological condition, weaning of the mechanical ventilation has to be initiated notably to prevent ventilator associated pneumonia and others complications. Nevertheless, extubation fai...
Severe brain-injured patients need mechanical ventilation with tracheal intubation. After treatment of the acute neurological condition, weaning of the mechanical ventilation has to be initiated notably to prevent ventilator associated pneumonia and others complications. Nevertheless, extubation failure is very common in this population due to residual neurological impairment with airway control alteration. Guidelines about weaning of mechanical ventilation and extubation exclude brain-injured patients with a residual impaired consciousness. In 2017, a simple and pragmatic extubation readiness clinical score was validated in a prospective observational cohort study of 140 brain injured patients. (Godet et al. Anesthesiology. 2017 Jan;126(1):104-114) In this study, brain injured patients with residual impaired consciousness who succeeded a spontaneous breathing trial were extubated. In multivariate analysis, 4 clinical elements were associated with extubation success. A prediction score was determined using the odds ratio such as followed : Deglutition: 3 points if present Gag reflex: 4 points if present Cough: 4 points if present CRS-R Score, visual item > 2, 3 points if present For a cut-off value of 9, extubation failure could be predicted with a sensibility of 84%, a specificity of 75%, a positive predictive value of 89% and a negative predictive value of 66%. In order to participate, brain-injured patients will have to succeed a spontaneous breathing trial and meet all inclusion criteria, including not being able to obey to simple orders without sedation. Using a stepped wedge randomisation process with intensive care units as clusters, patients will be weaned and extubated under usual care or using the extubation readiness clinical score. The authors' hypothesis is that this clinical score will allow physicians to extubate patients at the right time interval and prevent extubation failure in this frail population.
Tracking Information
- NCT #
- NCT04080440
- Collaborators
- AZUREA Network (www.azurea.org)
- ANARLF Network
- Direction Générale de l'Offre de Soin (DGOS)
- Investigators
- Study Director: Russell Chabanne University Hospital, Clermont-Ferrand Principal Investigator: Olivier Vincent University Hospital, Grenoble Principal Investigator: Florent Gobert Hospices Civils de Lyon Principal Investigator: Jérôme Morel CHU Saint-Etienne Principal Investigator: Matthieu Jeannot CH Valence Principal Investigator: Karim Asehnoune CHU Nantes Principal Investigator: Ségolène Mrozek CHU Toulouse Principal Investigator: Pierre-François Perrigault University Hospital, Montpellier Principal Investigator: Nicolas Bruder La Timone - Assistance Publique Hôpital de Marseille Principal Investigator: Claire Roger CHU Nîmes Principal Investigator: Carole Ichai CHU Nice Principal Investigator: Marc Leone Hôp Nord - Assistance Publique Hôpital de Marseille Principal Investigator: Christophe Lebard Fondation Ophtalmologique Adolphe de Rothschild Principal Investigator: Camille Bouisse CH de Bourg-en-Bresse
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