Brain-injured Patients Extubation Readiness Study (Biper)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Brain Injury; Mechanical Ventilation; Altered Level of Consciousness; Mechanical Ventilator Weaning; Airway Control
• Intervention / Treatment: Procedure: Standard of care; Procedure: Extubation readiness 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 660
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laclautre; Phone Number: +33 4 73 754963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Angers, France
    • Recruiting
    • CHU
    • Contact: Sigismond Lasocki
  • Bordeaux, France
    • Recruiting
    • CHU
    • Contact: Hugues De Courson
  • Bourg-en-Bresse, France
    • Terminated
    • CH
  • Caen, France
    • Recruiting
    • CHU
    • Contact: Clément Gakuba
  • Clermont-Ferrand, France
    • Recruiting
    • CHU
    • Contact: Russell Chabanne
  • Grenoble, France
    • Recruiting
    • CHU
    • Contact: Olivier Vincent
  • La Réunion, France
    • Recruiting
    • CHU
    • Contact: Sophie Kauffmann
  • Lille, France
    • Recruiting
    • CHU
    • Contact: Natalie De Sa
  • Lyon, France
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Florent Gobert
  • Marseille, France
    • Withdrawn
    • APHM
  • Montpellier, France
    • Recruiting
    • CHU
    • Contact: Pierre-François Perrigault
  • Nantes, France
    • Recruiting
    • CHU
    • Contact: Pierre-André Rodié-Talbère
  • Nice, France
    • Terminated
    • Pasteur 2 Hospital - University Hospital
  • Nîmes, France
    • Recruiting
    • CHU
    • Contact: Claire Roger
  • Paris, France
    • Recruiting
    • Fondation Ophtalmologique Adolphe de Rothschild
    • Contact: Mohamed Khemili
  • Poitiers, France
    • Recruiting
    • CHU
    • Contact: Claire Dahyot-Fizelier
  • Rennes, France
    • Recruiting
    • CHU
    • Contact: Yoann Launey
  • Saint-Etienne, France
    • Recruiting
    • CHU
    • Contact: Jérome Morel
  • Toulouse, France
    • Recruiting
    • CHU
    • Contact: Thomas Geeraerts
  • Valence, France
    • Terminated
    • CH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Clinicians decide whether to extubate or not following their ICU protocol	Procedure: Standard of care; 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
Experimental: Extubation readiness clinical score; Clinicians decide whether to extubate or not following the extubation readiness clinical score	Procedure: Extubation readiness clinical score; 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: AZUREA Network (www.azurea.org); ANARLF Network; Direction Générale de l'Offre de Soin (DGOS)
• Investigators: Principal Investigator: Carole Ichai, CHU Nice; Study Director: Russell Chabanne, University Hospital, Clermont-Ferrand; Principal Investigator: Olivier Vincent, University Hospital, Grenoble; Principal Investigator: Florent Gobert, Hospices Civils de Lyon; Principal Investigator: Jérôme Morel, CHU SAINT-ETIENNE; Principal Investigator: Matthieu Jeannot, CH Valence; Principal Investigator: Ségolène Mrozek, CHU Toulouse; Principal Investigator: Pierre-François Perrigault, University Hospital, Montpellier; Principal Investigator: Nicolas Bruder, La Timone - Assistance Publique Hôpital de Marseille; Principal Investigator: Marc Leone, Hôp Nord - Assistance Publique Hôpital de Marseille; Principal Investigator: Christophe Lebard, Fondation Ophtalmologique Adolphe de Rothschild; Principal Investigator: Camille Bouisse, CH de Bourg-en-Bresse; Principal Investigator: Claire Roger, CHU Nîmes; Principal Investigator: Karim Asehnoune, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2020
• Primary Completion (Estimated): March 13, 2027
• Study Completion (Estimated): October 13, 2027

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Critical care; Traumatic brain injury; Coma; Intensive care units; Anoxic ischemic encephalopathy; Glasgow coma scale
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Consciousness Disorders
• Other Study ID Numbers: Biper - PhrcIR 2017 Chabanne; 2018-A00894-51 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No