Clinical trial NCT04080440: Brain-injured Patients Extubation Readiness Study
Official title: Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mechanical Ventilator Weaning
Acute Brain Injury
Altered Level of Consciousness
Mechanical Ventilation
Airway Control
Keywords: Coma
Intensive care units
Critical care
Stroke
Traumatic brain injury
Anoxic ischemic encephalopathy
Glasgow coma scale
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: AZUREA Network (www.azurea.org)
name: ANARLF Network
name: Direction Générale de l'Offre de Soin (DGOS)
First posted: 2019-09-06
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped wedge, cluster randomised controlled design
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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 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
* Life expectancy less than 48 hours or withdrawal of life sustaining therapy
* Chronic respiratory failure
* More than 3 failed spontaneous breathing trials
* Chest trauma (more than 2 broken ribs / broken sternum / with an indication of open thoracic surgery)
* Surgery planned within 7 days
* Tracheotomy
* 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 ventilation weaning

Primary outcomes:
measure: Extubation failure
timeFrame: Day 5 (Day 0 = Extubation)
measure: Key secondary outcome meausure
timeFrame: Day 5 (Day 0 = Extubation)
Secondary outcomes:
measure: Invasive mechanical ventilation duration
timeFrame: End of the ICU Stay or Day 90 (Day 0 = Inclusion)
measure: Non-invasive mechanical ventilation duration
timeFrame: End of the ICU Stay or Day 90 (Day 0 = Inclusion)
measure: Reintubation rate
timeFrame: Until the end of the ICU Stay or until Day 90 (Day 0 = Inclusion)
measure: Reintubation rate in the first 48 hours
timeFrame: Until Day 2 (Day 0 = Extubation)
measure: Causes of reintubation
timeFrame: Until Day 5 (Day 0 = Extubation)
measure: ICU length of stay
timeFrame: End of ICU Stay or Day 90 (Day 0 = Inclusion)
measure: Post extubation nosocomial pneumonia
timeFrame: Until Day 5 (Day 0 = Extubation)
measure: Tracheotomy before extubation
timeFrame: Until the end of the ICU Stay or until Day 90 (Day 0 = inclusion)
measure: Tracheotomy after extubation
timeFrame: Until the end of the ICU Stay or until Day 90 (Day 0 = Inclusion)
measure: Neurological outcome
timeFrame: Day 90 (Day 0 = Inclusion)
measure: Hospital length of stay
timeFrame: End of Hospital Stay or until Day 90 (Day 0 = Inclusion)
measure: Mortality
timeFrame: Until the end of the ICU Stay or until Day 90 (Day 0 = Inclusion)
measure: Mortality
timeFrame: Day 28 (Day 0 = Inclusion)
measure: Mortality
timeFrame: Day 90 (Day 0 = Inclusion)
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
city: Bordeaux
country: France
facility: CHU
city: Bordeaux
country: France
facility: CHU
city: Bourg-en-Bresse
country: France
facility: CH
city: Caen
country: France
facility: CHU
city: Clermont-Ferrand
country: France
facility: CHU
city: Grenoble
country: France
facility: CHU
city: La Réunion
country: France
facility: CHU
city: Lille
country: France
facility: CHU
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: APHM
city: Montpellier
country: France
facility: CHU
city: Nantes
country: France
facility: CHU
city: Nice
country: France
facility: Pasteur 2 Hospital - University Hospital
city: Nîmes
country: France
facility: CHU
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Poitiers
country: France
facility: CHU
city: Rennes
country: France
facility: CHU
city: Saint-Etienne
country: France
facility: CHU
city: Toulouse
country: France
facility: CHU
city: Valence
country: France
facility: CH
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Russell Chabanne
role: STUDY_DIRECTOR
affiliation: University Hospital, Grenoble
name: Olivier Vincent
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: Florent Gobert
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU SAINT-ETIENNE
name: Jérôme Morel
role: PRINCIPAL_INVESTIGATOR
affiliation: CH VALENCE
name: Matthieu Jeannot
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Pierre-André Rodié-Talbère
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Toulouse
name: Thomas Geeraerts
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Montpellier
name: Pierre-François Perrigault
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Nîmes
name: Claire Roger
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU NICE
name: Carole Ichai
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Mohamed Khemili
role: PRINCIPAL_INVESTIGATOR
affiliation: CH de Bourg-en-Bresse
name: Camille Bouisse
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Lille
name: Natalie De Sa
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: Sigismond Lasocki
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Poitiers
name: Claire Dahyot-Fizelier
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Yoann Launey
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Bordeaux - Réanimation Chirurgicale et traumatologique
name: Laurent Petit
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Bordeaux - Réanimation Neurologique
name: Hugues De Courson
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Caen Normandie
name: Clément Gakuba
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de La Réunion
name: Sophie Kauffmann
role: PRINCIPAL_INVESTIGATOR
References: