Assessing readiness for extubation in brain-injured patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chu
  Angers, France Recruiting
• Chu
  Bordeaux, France Recruiting
• Chu
  Bordeaux, France Recruiting
• Chu
  Caen, France Recruiting
• Chu
  Clermont-Ferrand, France Recruiting
• Chu
  La Réunion, France Recruiting

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.