Brain-injured Patients Extubation Readiness Study
Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score
University Hospital, Clermont-Ferrand
660 participants
Feb 9, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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
- 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 Criteria14
- 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
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Interventions
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.
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.
Locations(21)
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NCT04080440