Brain-injured Patients Extubation Readiness Study

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Sep 4, 2019

Keywords

ClinConnect Summary

The Brain-injured Patients Extubation Readiness Study, or BIPER, is a clinical trial designed to help critically-ill patients with brain injuries who need to be taken off mechanical ventilation, which is a machine that helps them breathe. The study looks at using a simple scoring system to determine if these patients are ready to have their breathing tube removed, aiming to reduce the chances of complications after extubation, or the process of removing the tube.

To be eligible for this study, participants should be between 18 and 75 years old and have a recent brain injury that requires them to be in the intensive care unit (ICU) on a ventilator for more than 48 hours. They should also show some signs of stability, like being able to breathe on their own during certain tests. If someone meets these criteria and chooses to participate, they can expect to be part of a process that may help improve care for future patients with similar conditions. It's important to know that not everyone will qualify, as there are specific health conditions that could exclude them from the study.

Gender

ALL

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 or anoxo ischemic encephalopathy after cardiac arrest
• • 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
• • Life expectancy less than 48 hours or withdrawal of life sustaining therapy
• • Chronic respiratory failure
• • More than 3 failed spontaneous breathing trials
• • Chest trauma (more than 2 broken ribs / broken sternum / with an indication of open thoracic surgery)
• • Surgery planned within 7 days
• • Tracheotomy
• • 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 ventilation weaning