Brain-injured Patients Extubation Readiness Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Extubation 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.
• Процедура Usual 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.

Первичные конечные точки

• Extubation failure [Срок оценки: From extubation to Day 5 (120 hours) after extubation]

Вторичные конечные точки (12)

• Key secondary outcome measure: time to effective extubation [Срок оценки: From enrollment to day 5 (120 hours) after extubation]
• Invasive mechanical ventilation duration [Срок оценки: From admission to the end of ICU Stay]
• Non-invasive mechanical ventilation duration [Срок оценки: From admission to the end of ICU Stay]
• Reintubation rate in the first 48 hours [Срок оценки: From extubation to Day 2 after extubation (48 hours)]
• Reintubation rate in ICU [Срок оценки: From extubation to the end of ICU Stay]
• Post extubation nosocomial pneumonia [Срок оценки: From extubation to the end of ICU stay]
• Tracheotomy after extubation [Срок оценки: From extubation to the end of ICU Stay]
• Tracheotomy before extubation [Срок оценки: From enrollment to the end of ICU Stay]
• ICU length of stay [Срок оценки: From admission to the end of ICU Stay]
• Hospital length of stay [Срок оценки: From admission to the end of Hospital Stay]
• Mortality in ICU [Срок оценки: From enrollment to the end of the ICU Stay]
• Mortality at day 28 [Срок оценки: From enrollment to Day 28]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 21 центр

• CHU — Angers
• CHU — Bordeaux
• CHU — Bordeaux
• CH — Bourg-en-Bresse
• CHU — Caen
• CHU — Clermont-Ferrand
• CHU — Grenoble
• CHU — La Réunion
• … и ещё 13 центров

Публикации

• Godet T, Chabanne R, Marin J, Kauffmann S, Futier E, Pereira B, Constantin JM. Extubation Failure in Brain-injured Patients: Risk Factors and Development of a Prediction Score in a Preliminary Prospective Cohort Study. Anesthesiology. 2017 Jan;126(1):104-114. doi: 10.1097/ALN.0000000000001379. PMID 27749290
• Chabanne R, Godet T, Andanson B, Borrel P, Astier L, Caumon E, Bourguignon N, Laclautre L, Morand D, De Jong A, Futier E, Constantin JM, Pereira B, Jabaudon M. Prevention of extubation failure in neurocritical care patients with residual disorder of consciousness: the Brain-Injured Patients Extubation Readiness (BIPER) study protocol for a stepped-wedge cluster-randomised controlled trial. BMJ Ope PMID 40659406

Идентификаторы

NCT: NCT04080440 · Biper - PhrcIR 2017 Chabanne · 2018-A00894-51

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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