Brain-injured Patients Extubation Readiness Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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 : Deglutition: 3 points if present Gag reflex: 4 points if present Cough: 4 points if present 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.

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

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

Intervention / Treatment
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* Procedure: Extubation readiness clinical score
* Procedure: Standard of care


Participation Criteria
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Eligibility Criteria
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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 or anoxo ischemic encephalopathy after cardiac arrest Mechanical ventilation more than 48 hours 18 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stepped wedge, cluster randomised controlled design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>Clinicians decide whether to extubate or not following their ICU protocol | Procedure: Standard of care<br>* After treatment of the acute neurological condition, elligibility for a spontaneous breathing trial will be assessed 2 times a day. In the control group, after a successful spontaneous breathing trial in unconscious patients, the extubation will be achieved according to the standard of care<br>|
| Experimental: Extubation readiness clinical score<br>Clinicians decide whether to extubate or not following the extubation readiness clinical score | Procedure: Extubation readiness clinical score<br>* After treatment of the acute neurological condition, elligibility for a spontaneous breathing trial will be assessed 2 times 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation failure | Extubation failure is defined as a need of reintubation or death | Day 5 (Day 0 = Extubation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive mechanical ventilation duration | Period expressed in days during which patients will need invasive mechanical ventilation | End of the ICU Stay or Day 90 (Day 0 = Extubation) | 
| Non-invasive mechanical ventilation duration | Period expressed in days during which patients will need non-invasive mechanical ventilation | End of the ICU Stay or Day 90 (Day 0 = Extubation) | 
| Reintubation rate | Patients needing reintubation during entire ICU stay | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | 
| Reintubation rate | Patients needing reintubation during entire ICU stay | Until Day 2 (Day 0 = Extubation) | 
| Causes of reintubation | Causes of reintubation if needed | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | 
| ICU length of stay | ICU length of stay expressed in days | End of ICU Stay or Day 90 (Day 0 = Extubation) | 
| Post extubation nosocomial pneumonia | Post extubation nosocomial pneumonia is defined as a pulmonary infection after extubation that necessitate antibiotic therapy | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | 
| Tracheotomy before extubation | Number of patients that necessitate a tracheotomy after a successful spontaneous breathing trial but before extubation | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | 
| Tracheotomy after extubation | Number of patients that necessitate a tracheotomy afetr extubation failure | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | 
| Neurological outcome | Neurological outcome using the Glasgow Outcome Scale Extended | Day 90 (Day 0 = Extubation) | 
| Hospital length of stay | Hospital length of stay expressed in days | End of Hospital Stay or until Day 90 (Day 0 = Extubation) | 
| Mortality | Deceased patient in each group | Until the end of the ICU Stay or until Day 90 (Day 0 = Extubation) | 
| Mortality | Deceased patient in each group | Day 28 (Day 0 = Extubation) | 
| Mortality | Deceased patient in each group | Day 90 (Day 0 = Extubation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coma, Intensive care units, Critical care, Stroke, Traumatic brain injury, Anoxic ischemic encephalopathy, Glasgow coma scale