Brain-injured Patients Extubation Readiness Study

Last updated: September 23, 2025
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Neurologic Disorders

Treatment

Extubation readiness clinical score

Standard of care

Usual Care

Clinical Study ID

NCT04080440
Biper - PhrcIR 2017 Chabanne
2018-A00894-51
  • Ages 18-75
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Acute cerebral lesion with a Glasgow Coma Scale <13 needing admission in ICU andmechanical ventilation with tracheal intubation for neurological cause :cerebrovascular stroke either ischemic or hemorrhagic including aneurysmalsubarachnoid hemorrhage, traumatic brain injury, anoxo ischemic encephalopathy aftercardiac 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

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 supportventilation and/or proven COPD and/or ambulatory non-invasive CPAP therapy for sleepapnoea syndrome

  • More than 3 failed spontaneous breathing trials

  • Significant chest trauma (more than 2 broken ribs / broken sternum / with anindication 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

Study Design

Total Participants: 660
Treatment Group(s): 3
Primary Treatment: Extubation readiness clinical score
Phase:
Study Start date:
February 09, 2020
Estimated Completion Date:
October 13, 2027

Study Description

Severe brain-injured patients need mechanical ventilation with tracheal intubation. After treatment of the acute neurological condition, weaning of the mechanical ventilation has to be initiated notably to prevent ventilator associated pneumonia and others complications. Nevertheless, extubation failure is very common in this population due to residual neurological impairment with airway control alteration.

Guidelines about weaning of mechanical ventilation and extubation exclude brain-injured patients with a residual impaired consciousness.

In 2017, a simple and pragmatic extubation readiness clinical score was validated in a prospective observational cohort study of 140 brain injured patients. (Godet et al. Anesthesiology. 2017 Jan;126(1):104-114) In this study, brain injured patients with residual impaired consciousness who succeeded a spontaneous breathing trial were extubated. In multivariate analysis, 4 clinical elements were associated with extubation success. A prediction score was determined using the odds ratio such as followed :

  1. Deglutition: 3 points if present

  2. Gag reflex: 4 points if present

  3. Cough: 4 points if present

  4. CRS-R Score, visual item >2, 3 points if present, 1 point if not

For a cut-off value of 9, extubation failure could be predicted with a sensibility of 84%, a specificity of 75%, a positive predictive value of 89% and a negative predictive value of 66%.

In order to participate, brain-injured patients will have to succeed a spontaneous breathing trial and meet all inclusion criteria, including not being able to obey to command with no or minimal sedation. Using a stepped wedge randomisation process with intensive care units as clusters, patients will be weaned and extubated under usual care or using the extubation readiness clinical score.

The authors' hypothesis is that this clinical score will allow physicians to extubate patients at the right time interval and prevent extubation failure in this frail population.

Connect with a study center

  • CHU

    Angers,
    France

    Site Not Available

  • CHU

    Angers 3037656,
    France

    Active - Recruiting

  • CHU

    Bordeaux,
    France

    Site Not Available

  • CHU

    Bordeaux 3031582,
    France

    Active - Recruiting

  • CH

    Bourg-en-Bresse,
    France

    Site Not Available

  • CH

    Bourg-en-Bresse 3031009,
    France

    Terminated

  • CHU

    Caen,
    France

    Site Not Available

  • CHU

    Caen 3029241,
    France

    Active - Recruiting

  • CHU

    Clermont-Ferrand,
    France

    Site Not Available

  • CHU

    Clermont-Ferrand 3024635,
    France

    Active - Recruiting

  • CHU

    Grenoble,
    France

    Site Not Available

  • CHU

    Grenoble 3014728,
    France

    Completed

  • CHU

    La Réunion,
    France

    Site Not Available

  • CHU

    La Réunion 6619528,
    France

    Active - Recruiting

  • CHU

    Lille,
    France

    Site Not Available

  • CHU

    Lille 2998324,
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Lyon,
    France

    Site Not Available

  • Hospices Civils de Lyon

    Lyon 2996944,
    France

    Active - Recruiting

  • University hospital

    Marseile,
    France

    Site Not Available

  • APHM

    Marseille,
    France

    Site Not Available

  • APHM

    Marseille 2995469,
    France

    Site Not Available

  • CHU

    Montpellier,
    France

    Site Not Available

  • CHU

    Montpellier 2992166,
    France

    Active - Recruiting

  • CHU

    Nantes,
    France

    Site Not Available

  • CHU

    Nantes 2990969,
    France

    Completed

  • Pasteur 2 Hospital - University Hospital

    Nice,
    France

    Site Not Available

  • Pasteur 2 Hospital - University Hospital

    Nice 2990440,
    France

    Terminated

  • CHU

    Nîmes,
    France

    Site Not Available

  • CHU

    Nîmes 2990363,
    France

    Active - Recruiting

  • Fondation Ophtalmologique Adolphe de Rothschild

    Paris,
    France

    Site Not Available

  • Fondation Ophtalmologique Adolphe de Rothschild

    Paris 2988507,
    France

    Active - Recruiting

  • CHU

    Poitiers,
    France

    Site Not Available

  • CHU

    Poitiers 2986495,
    France

    Active - Recruiting

  • CHU

    Rennes,
    France

    Site Not Available

  • CHU

    Rennes 2983990,
    France

    Active - Recruiting

  • CHU

    Saint-Etienne,
    France

    Site Not Available

  • CHU

    Saint-Etienne 2980291,
    France

    Completed

  • CHU

    Toulouse,
    France

    Site Not Available

  • CHU

    Toulouse 2972315,
    France

    Active - Recruiting

  • CH

    Valence,
    France

    Site Not Available

  • CH

    Valence 2971053,
    France

    Terminated

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