Brain-injured Patients Extubation Readiness Study

Recruiting now · Not applicable

Conditions studied: Mechanical Ventilator Weaning, Acute Brain Injury, Altered Level of Consciousness, Mechanical Ventilation, Airway Control

In brief

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.

Key facts

Study ID

NCT04080440

Run by

University Hospital, Clermont-Ferrand

People needed

660

Starts

2020-02-09

Expected to finish

2027-10-13

Last updated by the study team

2025-09-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU — Nîmes, France (enrolling)
• Fondation Ophtalmologique Adolphe de Rothschild — Paris, France (enrolling)
• CHU — Poitiers, France (enrolling)
• CHU — Rennes, France (enrolling)
• CHU — Bordeaux, France (enrolling)
• CHU — Toulouse, France (enrolling)
• CHU — Angers, France (enrolling)
• CHU — La Réunion, France (enrolling)
• CHU — Lille, France (enrolling)
• Hospices Civils de Lyon — Lyon, France (enrolling)
• CHU — Bordeaux, France (enrolling)
• CHU — Montpellier, France (enrolling)
• CHU — Caen, France (enrolling)
• CHU — Clermont-Ferrand, France (enrolling)
• CH — Valence, France
• CH — Bourg-en-Bresse, France
• CHU — Grenoble, France
• APHM — Marseille, France
• CHU — Nantes, France
• Pasteur 2 Hospital - University Hospital — Nice, France
• CHU — Saint-Etienne, France

Full record on ClinicalTrials.gov

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