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)
Extubation failure — From extubation to Day 5 (120 hours) after extubation Extubation failure is defined as a need of reintubation or death in the 5 days (120 hours) following extubation
Trial sites (21)
Facility
City
Region
Status
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
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.
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