NCT04080440 Brain-injured Patients Extubation Readiness Study
| NCT ID | NCT04080440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Mechanical Ventilator Weaning |
| Study Type | INTERVENTIONAL |
| Enrollment | 660 participants |
| Start Date | 2020-02-09 |
| Primary Completion | 2027-02-13 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 660 participants in total. It began in 2020-02-09 with a primary completion date of 2027-02-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 clinical score.
Eligibility Criteria
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
Contact & Investigator
Russell Chabanne
STUDY DIRECTOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT04080440 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Mechanical Ventilator Weaning. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04080440 currently recruiting?
Yes, NCT04080440 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT04080440 trial being conducted?
This trial is being conducted at Angers, France, Bordeaux, France, Bordeaux, France, Bourg-en-Bresse, France and 11 additional locations.
Who is sponsoring the NCT04080440 clinical trial?
NCT04080440 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Russell Chabanne at University Hospital, Clermont-Ferrand. The trial plans to enroll 660 participants.