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Clinical Trials in France / NCT04080440
Recruiting Not applicable

Brain-injured Patients Extubation Readiness Study

NCT04080440 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-02-09
Last updated
2025-09-24

Condition(s) studied

Mechanical Ventilator WeaningAcute Brain InjuryAltered Level of ConsciousnessMechanical VentilationAirway Control

Investigational drug(s) / intervention(s)

Extubation readiness clinical scoreUsual Care

Extubation readiness clinical score: After treatment of the acute neurological condition, eligibility for a spontaneous breathing trial will be assessed once a day. In the intervention group, after a successful spontaneous breathing trial in unconscious patients, the score will be evaluated. If the score is \> 9, extubation has to be completed.

Usual Care: After treatment of the acute neurological condition, eligibility for a spontaneous breathing trial will be assessed once a day. In the control group, after a successful spontaneous breathing trial in unconscious patients, the extubation will be achieved according to usual care.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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, anoxo ischemic encephalopathy after cardiac arrest or brain tumour * 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 Exclusion Criteria: * 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 * Care limitation plan * Chronic respiratory failure defined as ambulatory oxygen therapy or pressure support ventilation and/or proven COPD and/or ambulatory non-invasive CPAP therapy for sleep apnoea syndrome * More than 3 failed spontaneous breathing trials * Significant chest trauma (more than 2 broken ribs / broken sternum / with an indication of open thoracic surgery) * Surgery planned within 7 days * Tracheotomy or previous extubation outside of the protocol * 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 mechanical ventilation or weaning

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
CHU Angers France Recruiting
CHU Bordeaux France Recruiting
CHU Bordeaux France Recruiting
CH Bourg-en-Bresse France Terminated
CHU Caen France Recruiting
CHU Clermont-Ferrand France Recruiting
CHU Grenoble France Completed
CHU La Réunion France Recruiting
CHU Lille France Recruiting
Hospices Civils de Lyon Lyon France Recruiting
APHM Marseille France Withdrawn
CHU Montpellier France Recruiting
CHU Nantes France Completed
Pasteur 2 Hospital - University Hospital Nice France Terminated
CHU Nîmes France Recruiting
Fondation Ophtalmologique Adolphe de Rothschild Paris France Recruiting
CHU Poitiers France Recruiting
CHU Rennes France Recruiting
CHU Saint-Etienne France Completed
CHU Toulouse France Recruiting
CH Valence France Terminated

More University Hospital, Clermont-Ferrand trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04080440 on ClinicalTrials.gov ↗ ← All trials in France