Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
660 participants
INTERVENTIONAL
2020-02-09
2027-10-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Usual care
Clinicians decide whether to extubate or not following usual care in their ICU ventilator weaning protocol
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.
Extubation readiness clinical score
Clinicians decide whether to extubate or not following the extubation readiness clinical score as part of their ICU ventilator weaning protocol
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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ANARLF Network
UNKNOWN
Direction Générale de l'Offre de Soin (DGOS)
UNKNOWN
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Russell Chabanne
Role: STUDY_DIRECTOR
University Hospital, Clermont-Ferrand
Olivier Vincent
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Florent Gobert
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Jérôme Morel
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Matthieu Jeannot
Role: PRINCIPAL_INVESTIGATOR
CH VALENCE
Pierre-André Rodié-Talbère
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Thomas Geeraerts
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Pierre-François Perrigault
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Claire Roger
Role: PRINCIPAL_INVESTIGATOR
CHU Nîmes
Carole Ichai
Role: PRINCIPAL_INVESTIGATOR
CHU NICE
Nicolas Engrand
Role: PRINCIPAL_INVESTIGATOR
Fondation Ophtalmologique Adolphe de Rothschild
Camille Bouisse
Role: PRINCIPAL_INVESTIGATOR
CH de Bourg-en-Bresse
Natalie De Sa
Role: PRINCIPAL_INVESTIGATOR
CHU Lille
Sigismond Lasocki
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Angers
Claire Dahyot-Fizelier
Role: PRINCIPAL_INVESTIGATOR
CHU Poitiers
Yoann Launey
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes
Laurent Petit
Role: PRINCIPAL_INVESTIGATOR
CHU Bordeaux - Réanimation Chirurgicale et traumatologique
Hugues De Courson
Role: PRINCIPAL_INVESTIGATOR
CHU Bordeaux - Réanimation Neurologique
Clément Gakuba
Role: PRINCIPAL_INVESTIGATOR
CHU Caen Normandie
Sophie Kauffmann
Role: PRINCIPAL_INVESTIGATOR
CHU de La Réunion
Locations
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CHU
Angers, , France
CHU
Bordeaux, , France
CHU
Bordeaux, , France
CH
Bourg-en-Bresse, , France
CHU
Caen, , France
CHU
Clermont-Ferrand, , France
CHU
Grenoble, , France
CHU
La Réunion, , France
CHU
Lille, , France
Hospices Civils de Lyon
Lyon, , France
APHM
Marseille, , France
CHU
Montpellier, , France
CHU
Nantes, , France
Pasteur 2 Hospital - University Hospital
Nice, , France
CHU
Nîmes, , France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, , France
CHU
Poitiers, , France
CHU
Rennes, , France
CHU
Saint-Etienne, , France
CHU
Toulouse, , France
CH
Valence, , France
Countries
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Central Contacts
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Facility Contacts
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Sigismond Lasocki
Role: primary
Laurent Petit
Role: primary
Hugues De Courson
Role: primary
Clément Gakuba
Role: primary
Russell Chabanne
Role: primary
Sophie Kauffmann
Role: primary
Natalie De Sa
Role: primary
Florent Gobert
Role: primary
Pierre-François Perrigault
Role: primary
Claire Roger
Role: primary
Nicolas Engrand
Role: primary
Claire Dahyot-Fizelier
Role: primary
Yoann Launey
Role: primary
Thomas Geeraerts
Role: primary
References
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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.
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.
Other Identifiers
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2018-A00894-51
Identifier Type: OTHER
Identifier Source: secondary_id
Biper - PhrcIR 2017 Chabanne
Identifier Type: -
Identifier Source: org_study_id
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