Status:
RECRUITING
Brain-injured Patients Extubation Readiness Study
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
ANARLF Network
Direction Générale de l'Offre de Soin (DGOS)
Conditions:
Mechanical Ventilator Weaning
Acute Brain Injury
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
Detailed Description
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 notab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 13 2027
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT04080440
Start Date
February 9 2020
End Date
October 13 2027
Last Update
September 24 2025
Active Locations (21)
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1
CHU
Angers, France
2
CHU
Bordeaux, France
3
CHU
Bordeaux, France
4
CH
Bourg-en-Bresse, France