NCT04080440Recruiting
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
Source: ClinicalTrials.gov · Last updated 24 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 660 (estimated)
- First submitted
- 4 Sept 2019
- Start date
- 9 Feb 2020
- Primary completion date
- 13 Feb 2027
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Diseases
- Stroke
- NCT number
- NCT04080440
What you commit to
- Study type: Interventional
- Planned participants: 660
- From 9 Feb 2020 to the primary completion date, 13 Feb 2027
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.