Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT04080440 En recrutement IDF

Titre

Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score (Biper)

Type

Interventional

Pathologie

Lésions encéphaliques
Troubles de la conscience

Phase

N/A

Promoteur

University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)

Date de début

février 2020

Date de fin

octobre 2027

Dernière mise à jour

28 juin 2024

Résumé

The BIPER study is a stepped wedge cluster randomised clinical trial aiming to decrease extubation failure in critically-ill brain-injured patients with residual impaired consciousness using a simple clinical score.

Détail

Voir le détail 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 : 1. Deglutition: 3 points if present 2. Gag reflex: 4 points if present 3. Cough: 4 points if present 4. CRS-R Score, visual item > 2, 3 points if present, 1 point if not 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. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FONDATION A. DE ROTHSCHILD	Mohamed KHEMILI	En recrutement IDF	21/06/2024 13:32:50	Contacter
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
APHM - Marseille - France		Annulé		Contact (sur clinicalTrials)
CHU - Bordeaux - France	Hugues De Courson	En recrutement		Contact (sur clinicalTrials)
CHU - Clermont-Ferrand - France	Russell Chabanne	En recrutement		Contact (sur clinicalTrials)
CHU - Nantes - France	Pierre-André Rodié-Talbère	En recrutement		Contact (sur clinicalTrials)
CHU - Saint-Etienne - France	Jérome Morel	En recrutement		Contact (sur clinicalTrials)
Hospices Civils de Lyon - Lyon - France	Florent Gobert	En recrutement		Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CH - Bourg-en-Bresse - France		Terminé		Contact (sur clinicalTrials)
CH - Valence - France		Terminé		Contact (sur clinicalTrials)
CHU - Angers - France	Sigismond Lasocki	En recrutement		Contact (sur clinicalTrials)
CHU - Caen - France	Clément Gakuba	En recrutement		Contact (sur clinicalTrials)
CHU - Grenoble - France	Olivier Vincent	En recrutement		Contact (sur clinicalTrials)
CHU - La Réunion - France	Sophie Kauffmann	En recrutement		Contact (sur clinicalTrials)
CHU - Lille - France	Natalie De Sa	En recrutement		Contact (sur clinicalTrials)
CHU - Montpellier - France	Pierre-François Perrigault	En recrutement		Contact (sur clinicalTrials)
CHU - Nîmes - France	Claire Roger	En recrutement		Contact (sur clinicalTrials)
CHU - Poitiers - France	Claire Dahyot-Fizelier	En recrutement		Contact (sur clinicalTrials)
CHU - Rennes - France	Yoann Launey	En recrutement		Contact (sur clinicalTrials)
CHU - Toulouse - France	Thomas Geeraerts	En recrutement		Contact (sur clinicalTrials)
Pasteur 2 Hospital - University Hospital - Nice - France		Terminé		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- Acute cerebral lesion with a Glasgow Coma Scale < 13 needing admission in ICU and
mechanical ventilation with tracheal intubation for neurological cause :
cerebrovascular stroke either ischemic or hemorrhagic including aneurysmal
subarachnoid hemorrhage, traumatic brain injury or anoxo ischemic encephalopathy
after cardiac arrest

- Mechanical ventilation more than 48 hours

- 18 to 75 years old

- Neurological stability with no intracranial hypertension with minimal sedation

- Glasgow Coma Scale motor response < 6

- Spontaneous breathing trial succeeded

- First extubation attempt

Critère de non inclusion

- Posterior cranial fossa lesion

- Admission for status epilepticus or central nervous system infection

- Spinal cord injury (tetraplegia or paraplegia)

- Uncontrolled status epilepticus or uncontrolled central nervous system infection

- Life expectancy less than 48 hours or withdrawal of life sustaining therapy

- Chronic respiratory failure

- More than 3 failed spontaneous breathing trials

- Chest trauma (more than 2 broken ribs / broken sternum / with an indication of open
thoracic surgery)

- Surgery planned within 7 days

- Tracheotomy

- Previous compromised upper airway permeability

- Pregnant or breastfeeding woman

- Adult under the protection of the law or without social assurance system

- Inclusion in another clinical study about ventilation weaning

NCT04080440 - Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score (Biper)

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