Testing a Simple Score to Judge Breathing Tube Removal in Brain-Injured Patients
Tests a simple clinical score to guide breathing tube removal in adults with brain injury.
Plain-language title generated from the registry record
Registry title: Brain-injured Patients Extubation Readiness Study
Key facts
- Where
- Angers, Bordeaux, Bourg-en-Bresse, Caen, Clermont-Ferrand, Grenoble, La Réunion, Lille, Lyon, Marseille, Montpellier, Nantes, Nice, Nîmes, Paris, Poitiers, Rennes, Saint-Etienne, Toulouse, and Valence, FranceSee the 20 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT04080440, who can take part
Where in France
- CHUAngers, FranceTaking people
- CHUBordeaux, FranceTaking people
- CHBourg-en-Bresse, FranceNo longer taking part
- CHUCaen, FranceTaking people
- CHUClermont-Ferrand, FranceTaking people
- CHUGrenoble, FranceNo longer taking part
- CHULa Réunion, FranceTaking people
- CHULille, FranceTaking people
- Hospices Civils de LyonLyon, FranceTaking people
- APHMMarseille, FranceNo longer taking part
- CHUMontpellier, FranceTaking people
- CHUNantes, FranceNo longer taking part
- Pasteur 2 Hospital - University HospitalNice, FranceNo longer taking part
- CHUNîmes, FranceTaking people
- Fondation Ophtalmologique Adolphe de RothschildParis, FranceTaking people
- CHUPoitiers, FranceTaking people
- CHURennes, FranceTaking people
- CHUSaint-Etienne, FranceNo longer taking part
- CHUToulouse, FranceTaking people
- CHValence, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Clermont-Ferrand
- Trial code
- NCT04080440
- Record updated
- 24 September 2025
- Original description
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.Read full original descriptionShow less
Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score
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.
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: 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; Admission for status epilepticus or central nervous system infection; Uncontrolled status epilepticus or uncontrolled central nervous system infection; 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; Posterior cranial fossa lesion; Spinal cord injury (tetraplegia or paraplegia); Care limitation plan; More than 3 failed spontaneous breathing trials; 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.