Assessing readiness for extubation in brain-injured patients
Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score
NA · University Hospital, Clermont-Ferrand · NCT04080440
This study is testing a new way to see if brain-injured patients are ready to be taken off a breathing machine to help them recover better and avoid complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 660 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand (other) |
| Locations | 21 sites (Angers and 20 other locations) |
| Trial ID | NCT04080440 on ClinicalTrials.gov |
What this trial studies
The BIPER study is a stepped wedge cluster randomized clinical trial designed to reduce extubation failure rates in critically ill brain-injured patients who have impaired consciousness. It utilizes a validated clinical score to evaluate extubation readiness after mechanical ventilation. The study focuses on patients with acute cerebral lesions who have been on mechanical ventilation for over 48 hours and have successfully completed a spontaneous breathing trial. By identifying key clinical indicators associated with extubation success, the study aims to improve patient outcomes and reduce complications related to prolonged mechanical ventilation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with acute brain injuries requiring mechanical ventilation and who have shown neurological stability.
Not a fit: Patients with posterior cranial fossa lesions, uncontrolled seizures, or those with a life expectancy of less than 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the extubation success rates and overall recovery of brain-injured patients requiring mechanical ventilation.
How similar studies have performed: Previous studies have shown success with similar clinical scoring approaches in predicting extubation outcomes in brain-injured patients, indicating a promising avenue for this research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 20 other locations
- 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)
Study contacts
- Principal investigator: Olivier Vincent — University Hospital, Grenoble
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33 4 73 754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mechanical Ventilator Weaning, Acute Brain Injury, Altered Level of Consciousness, Mechanical Ventilation, Airway Control, Coma, Intensive care units, Critical care