Extubation strategies in neuro-intensive care unit patients and associations with outcomes: the ENIO multicentre international observational study.

Weaning brain injury extubation intra-cranial haemorrhage subarachnoid haemorrhage tracheostomy traumatic brain injury ventilator liberation

Journal

Annals of translational medicine
ISSN: 2305-5839
Titre abrégé: Ann Transl Med
Pays: China
ID NLM: 101617978

Informations de publication

Date de publication:
Apr 2020
Historique:
entrez: 13 5 2020
pubmed: 13 5 2020
medline: 13 5 2020
Statut: ppublish

Résumé

Prolonged invasive ventilation is common in patients with severe brain injury. Information on optimal management of extubation and on the use of tracheostomy in these patients is scarce. International guidelines regarding the ventilator liberation and tracheostomy are currently lacking. The aim of 'Extubation strategies in Neuro-Intensive care unit patients and associations with Outcomes' (ENIO) study is to describe current management of weaning from invasive ventilation, focusing on decisions on timing of tracheal extubation and tracheostomy in intensive care unit (ICU) patients with brain injury. We conducted a prospective, international, multi-centre observational study enrolling patients with various types of brain injury, including trauma, stroke, and subarachnoid haemorrhage, with an initial Glasgow Coma Score equal or less than 12, and a duration of invasive ventilation longer than 24 hours from ICU admission. ENIO is expected to include at least 1,500 patients worldwide. The primary endpoint of the ENIO study is extubation success in the 48 hours following endotracheal tube removal. The primary objective is to validate a score predictive of extubation success. To accomplish this, the study population will be randomly divided to a development cohort (2/3 of the included patients) and a validation cohort (the remaining 1/3). Secondary objectives are: to determine the incidence of extubation success rate according to various time-frames (within 96 hours, >96 hours after extubation); to validate (existing) prediction scores for successful extubation according to various time-frames and definitions (i.e., tracheostomy as extubation failure); and to describe the current practices of extubation and tracheostomy, and their associations. ENIO will be the largest prospective observational study of ventilator liberation and tracheostomy practices in patients with severe brain injury undergoing invasive mechanical ventilation, providing a validated predictive score of successful extubation. The ENIO study is registered in the Clinical Trials database: NCT03400904.

Sections du résumé

BACKGROUND BACKGROUND
Prolonged invasive ventilation is common in patients with severe brain injury. Information on optimal management of extubation and on the use of tracheostomy in these patients is scarce. International guidelines regarding the ventilator liberation and tracheostomy are currently lacking.
METHODS METHODS
The aim of 'Extubation strategies in Neuro-Intensive care unit patients and associations with Outcomes' (ENIO) study is to describe current management of weaning from invasive ventilation, focusing on decisions on timing of tracheal extubation and tracheostomy in intensive care unit (ICU) patients with brain injury. We conducted a prospective, international, multi-centre observational study enrolling patients with various types of brain injury, including trauma, stroke, and subarachnoid haemorrhage, with an initial Glasgow Coma Score equal or less than 12, and a duration of invasive ventilation longer than 24 hours from ICU admission. ENIO is expected to include at least 1,500 patients worldwide. The primary endpoint of the ENIO study is extubation success in the 48 hours following endotracheal tube removal. The primary objective is to validate a score predictive of extubation success. To accomplish this, the study population will be randomly divided to a development cohort (2/3 of the included patients) and a validation cohort (the remaining 1/3). Secondary objectives are: to determine the incidence of extubation success rate according to various time-frames (within 96 hours, >96 hours after extubation); to validate (existing) prediction scores for successful extubation according to various time-frames and definitions (i.e., tracheostomy as extubation failure); and to describe the current practices of extubation and tracheostomy, and their associations.
DISCUSSION CONCLUSIONS
ENIO will be the largest prospective observational study of ventilator liberation and tracheostomy practices in patients with severe brain injury undergoing invasive mechanical ventilation, providing a validated predictive score of successful extubation.
TRIAL REGISTRATION BACKGROUND
The ENIO study is registered in the Clinical Trials database: NCT03400904.

Identifiants

pubmed: 32395547
doi: 10.21037/atm.2020.03.160
pii: atm-08-07-503
pmc: PMC7210208
doi:

Banques de données

ClinicalTrials.gov
['NCT03400904']

Types de publication

Journal Article

Langues

eng

Pagination

503

Informations de copyright

2020 Annals of Translational Medicine. All rights reserved.

Déclaration de conflit d'intérêts

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/atm.2020.03.160). Pr Karim Asehnoune received fees from Baxter, Edwards, LFB, Fisher and Payckel, out of the scope of the present work. The other authors have no conflicts of interest to declare.

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Auteurs

Raphaël Cinotti (R)

Department of Anaesthesia and Critical Care, Hôpital Guillaume et René Laennec, University Hospital of Nantes, Saint-Herblain, France.

Paolo Pelosi (P)

Departement of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.
Anesthesia and Intensive Care, San Martino Policlinico Hospital IRCCS for Oncology and Neurosciences, Genoa, Italy.

Marcus J Schultz (MJ)

Amsterdam University Medical Centers, location 'AMC', Amsterdam, The Netherlands.
Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand.
Nuffield Department of Medicine, University of Oxford, Oxford, UK.

Ioakeimidou Aikaterini (I)

Department of Intensive Care Unit General Hospital of Athens, Greece.

Pablo Alvarez (P)

Intensive Care Unit, Maciel Hospital, Montevideo Uruguay, Montevideo, Uruguay.

Rafael Badenes (R)

Department of Anesthesiology and Surgical-Trauma Intensive Care, Hiospital Clínic Universitari de Valencia, Spain.
Department of Surgery, University of Valencia, Valencia, Spain.

Victoria Mc Credie (V)

Interdepartmental Division of Critical Care Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.
Division of Critical Care Medicine, Department of Medicine, University Health Network, Toronto, ON, Canada.

Abdurrahmaan Suei Elbuzidi (AS)

Department of Medicine, Medical Intensive Unit, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.

Muhammed Elhadi (M)

Faculty of Medicine, University of Tripoli, Tripoli, Libya.

Daniel Agustin Godoy (DA)

Neurointensive Care Unit, Sanatorio Pasteur, Hospital San Juan Bautista, Catamarca, Argentina.

Mohan Gurjar (M)

Department of Critical Care Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow, India.

Matthias Haenggi (M)

Department of Intensive Care Medicine, Inselspital, University Hospital, University of Bern, Bern, Switzerland.

Callum Kaye (C)

NHS Grampian, Aberdeen, UK.

Julio Cesar Mijangos-Méndez (JC)

Intensive Care Unit, Hospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Jalisco, Mexico.
Departamento de Clinicas Medicas, Division de Disciplinas Clínicas, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Jalisco, Mexico.

Michael Piagnerelli (M)

CHU-Charleroi, Marie Curie, Université Libre de Bruxelles, Charleroi, Belgium.

Romain Piracchio (R)

Department of Anesthesia and Perioperative Care, UCSF, San Francisco, CA, USA.

Syed Tariq Reza (ST)

Intensive Care Unit, Dhaka Medical College, Dhaka, Bangladesh.

Robert D Stevens (RD)

Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Ueno Yoshitoyo (U)

Emergency and Critical Care Medicine, Tokushima University Hospital, Tokushima, Japan.

Karim Asehnoune (K)

Department of Anaesthesia and Critical Care, Hôtel Dieu, University Hospital of Nantes, Nantes, France.

Classifications MeSH