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.
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
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
Parallel
Extubation readiness clinical score
Procedure/SurgeryAfter 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
Procedure/SurgeryAfter 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.
Extubation failure
Extubation failure is defined as a need of reintubation or death in the 5 days (120 hours) following extubation
Key secondary outcome measure: time to effective extubation
Time from SBT success (enrollment) to successful liberation from mechanical ventilation, defined as the time point at which a patient is alive and free of invasive ventilatory support for more than 5 days (120 hours)
Invasive mechanical ventilation duration
Period expressed in days during which patients will need invasive mechanical ventilation
Non-invasive mechanical ventilation duration
Period expressed in days during which patients will need non-invasive mechanical ventilation
Reintubation rate in the first 48 hours
Patients needing reintubation during the first 48h post-extubation
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University Hospital, Clermont-Ferrand
Lead sponsor
ANARLF Network
Collaborator
Direction Générale de l'Offre de Soin (DGOS)
Collaborator
