Brain-injured Patients Extubation Readiness Study

University Hospital, Clermont-Ferrand660 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

660

Conditions

Mechanical Ventilator Weaning Acute Brain Injury Altered Level of Consciousness Mechanical Ventilation Airway Control

Interventions

Extubation readiness clinical scorePROCEDURE

After treatment of the acute neurological condition, eligibility for a spontaneous breathing trial will be assessed once a day. In the intervention group, after a successful spontaneous breathing trial in unconscious patients, the score will be evaluated. If the score is \> 9, extubation has to be completed.

Usual CarePROCEDURE

After treatment of the acute neurological condition, eligibility for a spontaneous breathing trial will be assessed once a day. In the control group, after a successful spontaneous breathing trial in unconscious patients, the extubation will be achieved according to usual care.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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 support ventilation and/or proven COPD and/or ambulatory non-invasive CPAP therapy for sleep apnoea syndrome * More than 3 failed spontaneous breathing trials * 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 * 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

Locations (21)

CHU

Angers, France

RECRUITING

CHU

Bordeaux, France

Outcomes

Primary Outcomes

Extubation failure

Extubation failure is defined as a need of reintubation or death in the 5 days (120 hours) following extubation

Time frame: From extubation to Day 5 (120 hours) after extubation

Secondary Outcomes

Key secondary outcome measure: time to effective extubation

Time from SBT success (enrollment) to successful liberation from mechanical ventilation, defined as the time point at which a patient is alive and free of invasive ventilatory support for more than 5 days (120 hours)

Time frame: From enrollment to day 5 (120 hours) after extubation

Invasive mechanical ventilation duration

Period expressed in days during which patients will need invasive mechanical ventilation

Time frame: From admission to the end of ICU Stay

Non-invasive mechanical ventilation duration

Period expressed in days during which patients will need non-invasive mechanical ventilation

Time frame: From admission to the end of ICU Stay

Reintubation rate in the first 48 hours

Patients needing reintubation during the first 48h post-extubation

Time frame: From extubation to Day 2 after extubation (48 hours)

Reintubation rate in ICU

Patients needing reintubation during entire ICU stay

Time frame: From extubation to the end of ICU Stay

Post extubation nosocomial pneumonia

Post extubation nosocomial pneumonia is defined as a pulmonary infection after extubation that necessitate antibiotic therapy

Central Contacts

Lise Laclautre

CONTACT

+33 4 73 754963 promo_interne_drci@chu-clermontferrand.fr

Data from ClinicalTrials.gov

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