Brain-injured Patients Extubation Readiness Study

NCT04080440 | Recruiting

• 2 other identifiers: Biper - PhrcIR 2017 Chabanne2018-A00894-51
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 21

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.

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

Outcome Measures

Primary Outcomes (1)

• Extubation failure

  Extubation failure is defined as a need of reintubation or death in the 5 days (120 hours) following extubation

  From extubation to Day 5 (120 hours) after extubation

Secondary Outcomes (14)

• 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

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Clinicians decide whether to extubate or not following usual care in their ICU ventilator weaning protocol

Procedure: Usual Care

Extubation readiness clinical score

EXPERIMENTAL

Clinicians decide whether to extubate or not following the extubation readiness clinical score as part of their ICU ventilator weaning protocol

Procedure: Extubation readiness clinical score

Interventions

Extubation readiness clinical score PROCEDURE

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.

Extubation readiness clinical score

Usual Care PROCEDURE

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.

Usual care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• ANARLF Network: collaborator
• Direction Générale de l'Offre de Soin (DGOS): collaborator

Study Sites (21)

CHU

Angers, France

RECRUITING

CHU

Bordeaux, France

RECRUITING

CHU

Bordeaux, France

RECRUITING

CH

Bourg-en-Bresse, France

TERMINATED

CHU

Caen, France

RECRUITING

CHU

Clermont-Ferrand, France

RECRUITING

CHU

Grenoble, France

COMPLETED

CHU

La Réunion, France

RECRUITING

CHU

Lille, France

RECRUITING

Hospices Civils de Lyon

Lyon, France

RECRUITING

APHM

Marseille, France

WITHDRAWN

CHU

Montpellier, France

RECRUITING

CHU

Nantes, France

COMPLETED

Pasteur 2 Hospital - University Hospital

Nice, France

TERMINATED

CHU

Nîmes, France

RECRUITING

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

RECRUITING

CHU

Poitiers, France

RECRUITING

CHU

Rennes, France

RECRUITING

CHU

Saint-Etienne, France

COMPLETED

CHU

Toulouse, France

RECRUITING

CH

Valence, France

TERMINATED

Related Publications (2)

• 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 BACKGROUND

• 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 Open. 2025 Jul 13;15(7):e104897. doi: 10.1136/bmjopen-2025-104897.

  PMID: 40659406 DERIVED

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders; Coma; Stroke; Brain Injuries, Traumatic; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Unconsciousness; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Hypoxia, Brain; Hypoxia; Signs and Symptoms, Respiratory

Study Officials

• Russell Chabanne

  University Hospital, Clermont-Ferrand

  STUDY DIRECTOR

• 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

• Pierre-André Rodié-Talbère

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Thomas Geeraerts

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

• Pierre-François Perrigault

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

• Claire Roger

  CHU Nîmes

  PRINCIPAL INVESTIGATOR

• Carole Ichai

  CHU NICE

  PRINCIPAL INVESTIGATOR

• Nicolas Engrand

  Fondation Ophtalmologique Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

• Camille Bouisse

  CH de Bourg-en-Bresse

  PRINCIPAL INVESTIGATOR

• Natalie De Sa

  CHU Lille

  PRINCIPAL INVESTIGATOR

• Sigismond Lasocki

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

• Claire Dahyot-Fizelier

  CHU Poitiers

  PRINCIPAL INVESTIGATOR

• Yoann Launey

  CHU Rennes

  PRINCIPAL INVESTIGATOR

• Laurent Petit

  CHU Bordeaux - Réanimation Chirurgicale et traumatologique

  PRINCIPAL INVESTIGATOR

• Hugues De Courson

  CHU Bordeaux - Réanimation Neurologique

  PRINCIPAL INVESTIGATOR

• Clément Gakuba

  CHU Caen Normandie

  PRINCIPAL INVESTIGATOR

• Sophie Kauffmann

  CHU de La Réunion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 73 754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge, cluster randomised controlled design

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 6, 2019
• Study Start: February 9, 2020
• Primary Completion (Estimated): February 13, 2027
• Study Completion (Estimated): October 13, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: As soon as study publication in a peer review journal with a 5 years limit.
• Access Criteria: Data will be made available on reasonable demand by emailing the coordinating clinical investigator of the trial. A proposal that describes planned analyses will have to be submitted and a data sharing agreement signed. Requests will be evaluated by the coordinating clinical investigator and study statistician of the trial.

Locations

FR (21)