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Recruiting NCT04080440

Brain-injured Patients Extubation Readiness Study

Trial Parameters

Condition Mechanical Ventilator Weaning
Sponsor University Hospital, Clermont-Ferrand
Study Type INTERVENTIONAL
Phase N/A
Enrollment 660
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2020-02-09
Completion 2027-02-13
Interventions
Extubation readiness clinical scoreUsual Care

Brief 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 Criteria

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

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