Brain-injured Patients Extubation Readiness Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Extubation readiness clinical score
  • Usual Care

Treatment groups

660 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Clermont-Ferrand

Lead sponsor

ANARLF Network

Collaborator

Direction Générale de l'Offre de Soin (DGOS)

Collaborator