Brain-injured Patients Extubation Readiness Study

Last updated: June 25, 2024
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

Extubation readiness clinical score

Standard of 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 or anoxo ischemic encephalopathyafter 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

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 openthoracic 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

Study Design

Total Participants: 660
Treatment Group(s): 2
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 simple orders without 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

    Active - Recruiting

  • CHU

    Bordeaux,
    France

    Active - Recruiting

  • CH

    Bourg-en-Bresse,
    France

    Terminated

  • CHU

    Caen,
    France

    Active - Recruiting

  • CHU

    Clermont-Ferrand,
    France

    Active - Recruiting

  • CHU

    Grenoble,
    France

    Active - Recruiting

  • CHU

    La Réunion,
    France

    Active - Recruiting

  • CHU

    Lille,
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Lyon,
    France

    Active - Recruiting

  • University hospital

    Marseile,
    France

    Site Not Available

  • APHM

    Marseille,
    France

    Site Not Available

  • CHU

    Montpellier,
    France

    Active - Recruiting

  • CHU

    Nantes,
    France

    Active - Recruiting

  • Pasteur 2 Hospital - University Hospital

    Nice,
    France

    Terminated

  • CHU

    Nîmes,
    France

    Active - Recruiting

  • Fondation Ophtalmologique Adolphe de Rothschild

    Paris,
    France

    Active - Recruiting

  • CHU

    Poitiers,
    France

    Active - Recruiting

  • CHU

    Rennes,
    France

    Active - Recruiting

  • CHU

    Saint-Etienne,
    France

    Active - Recruiting

  • CHU

    Toulouse,
    France

    Active - Recruiting

  • CH

    Valence,
    France

    Terminated

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