Brain-injured Patients Extubation Readiness Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    660
  • sponsor
    University Hospital, Clermont-Ferrand
Updated on 13 July 2020
Investigator
Lise Laclautre
Primary Contact
CH (0.0 mi away) Contact
+12 other location
mechanical ventilation
stroke
intubation
cardiac arrest
extubation
cerebral lesion
traumatic brain injury
coma

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.

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 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.

Details
Treatment Standard of Care, Extubation readiness clinical score
Clinical Study IdentifierNCT04080440
SponsorUniversity Hospital, Clermont-Ferrand
Last Modified on13 July 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Brain Injury or Ventilator Weaning or Airway Management or Depressed Level of Consciousness or Artificial respiration?
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
to 75 yers old
Neurological stability with no intracranial hypertension with minimal sedation
Glasgow Coma Scale motor response < 6
Spontaneous breathing trial succeeded
First extubation attempt
Affiliated to French Social Assurance System

Exclusion Criteria

Posterior Cerebral Fossa lesion
Status epilepticus
Spinal cord injury (tetraplegia or paraplegia)
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
Surgery planned within 7 days
Tracheotomy
Previous compromised upper airway permeability
Pregnant woman
Adult under the protection of the law
Clear my responses

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