Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 660
- Locations
- 23
- Primary Endpoint
- Extubation failure
Study Overview
Brief 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.
Detailed 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 :
- 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, 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%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Extubation failure
Time Frame: From extubation to Day 5 (120 hours) after extubation
Extubation failure is defined as a need of reintubation or death in the 5 days (120 hours) following extubation
Secondary Outcomes
- Key secondary outcome measure: time to effective extubation(From enrollment to day 5 (120 hours) after extubation)
- Invasive mechanical ventilation duration(From admission to the end of ICU Stay)
- Non-invasive mechanical ventilation duration(From admission to the end of ICU Stay)
- Reintubation rate in the first 48 hours(From extubation to Day 2 after extubation (48 hours))
- Reintubation rate in ICU(From extubation to the end of ICU Stay)
- Post extubation nosocomial pneumonia(From extubation to the end of ICU stay)
- Tracheotomy after extubation(From extubation to the end of ICU Stay)
- Tracheotomy before extubation(From enrollment to the end of ICU Stay)
- ICU length of stay(From admission to the end of ICU Stay)
- Hospital length of stay(From admission to the end of Hospital Stay)
- Mortality in ICU(From enrollment to the end of the ICU Stay)
- Mortality at day 28(From enrollment to Day 28)
- Mortality at day 90(From enrollment to Day 90)
- Neurological outcome(Day 90 after enrollment)