Acute Brain Injury, Airway Control, Altered Level of Consciousness, Mechanical Ventilation, Mechanical Ventilator Weaning
Conditions
Keywords
Coma, Intensive care units, Critical care, Stroke, Traumatic brain injury, Anoxic ischemic encephalopathy, Glasgow coma scale
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 : 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.
Interventions
PROCEDUREExtubation readiness clinical score
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.
PROCEDUREUsual Care
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.
Sponsors
ANARLF Network
Direction Générale de l'Offre de Soin (DGOS)
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Stepped wedge, cluster randomised controlled design
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extubation failure | 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
| Measure | Time frame | Description |
|---|---|---|
| Invasive mechanical ventilation duration | From admission to the end of ICU Stay | Period expressed in days during which patients will need invasive mechanical ventilation |
| Non-invasive mechanical ventilation duration | From admission to the end of ICU Stay | Period expressed in days during which patients will need non-invasive mechanical ventilation |
| Reintubation rate in the first 48 hours | From extubation to Day 2 after extubation (48 hours) | Patients needing reintubation during the first 48h post-extubation |
| Reintubation rate in ICU | From extubation to the end of ICU Stay | Patients needing reintubation during entire ICU stay |
| Post extubation nosocomial pneumonia | From extubation to the end of ICU stay | Post extubation nosocomial pneumonia is defined as a pulmonary infection after extubation that necessitate antibiotic therapy |
| Tracheotomy after extubation | From extubation to the end of ICU Stay | Number of patients that necessitate a tracheotomy after extubation failure |
| Key secondary outcome measure: time to effective extubation | From enrollment to day 5 (120 hours) after 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) |
| ICU length of stay | From admission to the end of ICU Stay | ICU length of stay expressed in days |
| Hospital length of stay | From admission to the end of Hospital Stay | Hospital length of stay expressed in days |
| Mortality in ICU | From enrollment to the end of the ICU Stay | Deceased patient in each group during ICU stay |
| Mortality at day 28 | From enrollment to Day 28 | Deceased patient in each group at day 28 |
| Mortality at day 90 | From enrollment to Day 90 | Deceased patient in each group at day 90 |
| Neurological outcome | Day 90 after enrollment | Neurological outcome using the Glasgow Outcome Scale Extended |
| Tracheotomy before extubation | From enrollment to the end of ICU Stay | Number of patients that necessitate a tracheotomy after a successful spontaneous breathing trial but before any extubation |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed