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NCT04080440Recruiting

Brain-injured Patients Extubation Readiness Study

Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score

Source: ClinicalTrials.gov · Last updated 24 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
660 (estimated)
First submitted
4 Sept 2019
Start date
9 Feb 2020
Primary completion date
13 Feb 2027
Lead sponsor
University Hospital, Clermont-Ferrand
Diseases
Stroke
NCT number
NCT04080440

What you commit to

  • Study type: Interventional
  • Planned participants: 660
  • From 9 Feb 2020 to the primary completion date, 13 Feb 2027
  • 20 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Admission for status epilepticus or central nervous system infection
  • Uncontrolled status epilepticus or uncontrolled central nervous system infection
  • 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

Other

  • Posterior cranial fossa lesion
  • Spinal cord injury (tetraplegia or paraplegia)
  • Care limitation plan
  • More than 3 failed spontaneous breathing trials
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU
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AngersFranceRecruiting
CHU
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BordeauxFranceRecruiting
CH
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Bourg-en-BresseFranceTerminated
CHU
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CaenFranceRecruiting
CHU
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Clermont-FerrandFranceRecruiting
CHU
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GrenobleFranceCompleted
CHU
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La RéunionFranceRecruiting
CHU
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LilleFranceRecruiting
Hospices Civils de Lyon
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LyonFranceRecruiting
APHM
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MarseilleFranceWithdrawn
CHU
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MontpellierFranceRecruiting
CHU
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NantesFranceCompleted
Pasteur 2 Hospital - University Hospital
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NiceFranceTerminated
CHU
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NîmesFranceRecruiting
Fondation Ophtalmologique Adolphe de Rothschild
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ParisFranceRecruiting
CHU
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PoitiersFranceRecruiting
CHU
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RennesFranceRecruiting
CHU
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Saint-EtienneFranceCompleted
CHU
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ToulouseFranceRecruiting
CH
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ValenceFranceTerminated

This page is information, not medical advice. Discuss any trial with your doctor.