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 Article Swipe
Russell Chabanne
,
Thomas Godet
,
Benjamin Andanson
,
Pierre Borrel
,
Léo Astier
,
Elodie Caumon
,
Nathalie Bourguignon
,
Lise Laclautre
,
Dominique Morand
,
Audrey De Jong
,
Emmanuel Futier
,
Jean-Michel Constantin
,
Bruno Pereira
,
Matthieu Jabaudon
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2025-104897
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2025-104897
Introduction In the intensive care unit (ICU), brain-injured patients are frequently exposed to mechanical ventilation to protect the brain and preserve physiology. After intracranial pressure control and sedation withdrawal, this population is prone to residual disorder of consciousness and altered neurological control of respiratory drive, cough and airway protection. Consequently, extubation failure is more frequent than in general ICU patients, and there is no clear evidence-based clinical trigger for extubation. Different risk factors for extubation failure were described in observational trials, and clinical scores were constructed to detect patients at higher risk of extubation failure. Nevertheless, none of these scores were prospectively tested as interventional tools to prevent extubation failure. The Brain-Injured Patients Extubation Readiness (BIPER) study is an ongoing multicentre stepped-wedge cluster-randomised controlled trial aiming to test one of these scores as an intervention protocol to decrease extubation failure in neurocritical care patients with residual disorder of consciousness. Methods and analysis Trial design: Stepped-wedge cluster-randomised controlled trial with five groups of three to six clusters (20 ICUs). Groups of clusters are randomised to five possible sequences of nine periods with crossing from a control condition period (usual care for extubation) to an intervention condition period (BIPER-guided extubation protocol), separated by a 3-month transition period. Participants: Participants are clinically stable brain-injured patients (18–75 years old), requiring more than 48 hours of invasive mechanical ventilation with residual disorder of consciousness after sedation withdrawal, and who achieved a spontaneous breathing trial. Interventions: The control condition consists of extubation based on usual care and local practice. The intervention condition consists of extubation triggered by a clinical score evaluating deglutition, gag reflex, cough and visual tracking (Coma Recovery Scale-Revised Visual Scale). Objective: To determine whether adoption of an extubation protocol based on a clinical score can lessen extubation failure compared with usual care in brain-injured patients with residual disorder of consciousness. Outcome: The primary outcome measure is extubation failure, defined within 5 days following extubation. The key secondary outcome measure is time to effective extubation. Randomisation: Clusters are allocated to sequence of treatments using random blocks randomisation. The constitution of groups of clusters was stratified according to planned recruitment of each centre. Blinding: Investigators and outcome assessors are not blinded to condition allocation. Number of participants: 660 patients (220 in the control condition and 440 in the intervention condition). Ethics and dissemination The BIPER trial was approved by an independent ethics committee. The study began on 9 February 2020, and 571 participants are now included. Results will be published in an international peer-reviewed medical journal. Trial registration number NCT04080440 .
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/bmjopen-2025-104897
- OA Status
- gold
- References
- 43
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4412378816
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4412378816Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1136/bmjopen-2025-104897Digital Object Identifier
- Title
-
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 trialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2025Year of publication
- Publication date
-
2025-07-01Full publication date if available
- Authors
-
Russell Chabanne, Thomas Godet, Benjamin Andanson, Pierre Borrel, Léo Astier, Elodie Caumon, Nathalie Bourguignon, Lise Laclautre, Dominique Morand, Audrey De Jong, Emmanuel Futier, Jean-Michel Constantin, Bruno Pereira, Matthieu JabaudonList of authors in order
- Landing page
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https://doi.org/10.1136/bmjopen-2025-104897Publisher landing page
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://doi.org/10.1136/bmjopen-2025-104897Direct OA link when available
- Concepts
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Medicine, Neurointensive care, Intensive care, Randomized controlled trial, Mechanical ventilation, Intensive care unit, Sedation, Population, Observational study, Anesthesia, Emergency medicine, Intensive care medicine, Surgery, Internal medicine, Environmental healthTop concepts (fields/topics) attached by OpenAlex
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0Total citation count in OpenAlex
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43Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.assessors | 362 |
| abstract_inverted_index.breathing | 237 |
| abstract_inverted_index.condition | 185, 194, 242, 255, 367, 378 |
| abstract_inverted_index.described | 77 |
| abstract_inverted_index.determine | 279 |
| abstract_inverted_index.effective | 329 |
| abstract_inverted_index.following | 319 |
| abstract_inverted_index.included. | 410 |
| abstract_inverted_index.intensive | 3 |
| abstract_inverted_index.patients, | 59 |
| abstract_inverted_index.practice. | 252 |
| abstract_inverted_index.published | 414 |
| abstract_inverted_index.requiring | 215 |
| abstract_inverted_index.secondary | 323 |
| abstract_inverted_index.separated | 199 |
| abstract_inverted_index.sequences | 176 |
| abstract_inverted_index.triggered | 259 |
| abstract_inverted_index.Extubation | 113 |
| abstract_inverted_index.Objective: | 277 |
| abstract_inverted_index.clinically | 208 |
| abstract_inverted_index.committee. | 397 |
| abstract_inverted_index.controlled | 123, 156 |
| abstract_inverted_index.evaluating | 264 |
| abstract_inverted_index.extubation | 50, 74, 93, 108, 138, 197, 245, 258, 284, 293, 313 |
| abstract_inverted_index.frequently | 10 |
| abstract_inverted_index.mechanical | 13, 222 |
| abstract_inverted_index.population | 30 |
| abstract_inverted_index.protocol), | 198 |
| abstract_inverted_index.randomised | 172 |
| abstract_inverted_index.stratified | 350 |
| abstract_inverted_index.transition | 203 |
| abstract_inverted_index.treatments | 338 |
| abstract_inverted_index.NCT04080440 | 424 |
| abstract_inverted_index.allocation. | 368 |
| abstract_inverted_index.condition). | 384 |
| abstract_inverted_index.constructed | 85 |
| abstract_inverted_index.extubation) | 190 |
| abstract_inverted_index.extubation. | 69, 320, 330 |
| abstract_inverted_index.independent | 395 |
| abstract_inverted_index.multicentre | 120 |
| abstract_inverted_index.physiology. | 21 |
| abstract_inverted_index.protection. | 48 |
| abstract_inverted_index.recruitment | 354 |
| abstract_inverted_index.respiratory | 43 |
| abstract_inverted_index.spontaneous | 236 |
| abstract_inverted_index.ventilation | 14, 223 |
| abstract_inverted_index.withdrawal, | 28, 231 |
| abstract_inverted_index.Introduction | 0 |
| abstract_inverted_index.Participants | 206 |
| abstract_inverted_index.constitution | 344 |
| abstract_inverted_index.deglutition, | 265 |
| abstract_inverted_index.intervention | 134, 193, 254, 383 |
| abstract_inverted_index.intracranial | 23 |
| abstract_inverted_index.neurological | 40 |
| abstract_inverted_index.participants | 407 |
| abstract_inverted_index.registration | 422 |
| abstract_inverted_index.(BIPER-guided | 196 |
| abstract_inverted_index.Brain-Injured | 111 |
| abstract_inverted_index.Consequently, | 49 |
| abstract_inverted_index.Investigators | 359 |
| abstract_inverted_index.Nevertheless, | 95 |
| abstract_inverted_index.Participants: | 205 |
| abstract_inverted_index.Scale-Revised | 274 |
| abstract_inverted_index.Stepped-wedge | 154 |
| abstract_inverted_index.brain-injured | 7, 210, 300 |
| abstract_inverted_index.consciousness | 37, 228 |
| abstract_inverted_index.dissemination | 387 |
| abstract_inverted_index.international | 417 |
| abstract_inverted_index.neurocritical | 141 |
| abstract_inverted_index.observational | 79 |
| abstract_inverted_index.participants: | 371 |
| abstract_inverted_index.peer-reviewed | 418 |
| abstract_inverted_index.prospectively | 101 |
| abstract_inverted_index.stepped-wedge | 121 |
| abstract_inverted_index.Interventions: | 239 |
| abstract_inverted_index.Randomisation: | 331 |
| abstract_inverted_index.consciousness. | 148, 306 |
| abstract_inverted_index.evidence-based | 65 |
| abstract_inverted_index.interventional | 104 |
| abstract_inverted_index.randomisation. | 342 |
| abstract_inverted_index.cluster-randomised | 122, 155 |
| cited_by_percentile_year | |
| countries_distinct_count | 1 |
| institutions_distinct_count | 14 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.8199999928474426 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.41183649 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |