Mechanical Ventilator WeaningBiperNCT04080440
Brain-injured Patients Extubation Readiness Study
A study testing Extubation readiness clinical score in people with Mechanical Ventilator Weaning and Acute Brain Injury, run by University Hospital, Clermont-Ferrand at 21 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mechanical Ventilator Weaning, Acute Brain Injury, Altered Level of Consciousness
- What is being tested?
- Extubation readiness clinical score
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 21 sitesFrance
- Study dates
- 9 Feb 2020to 13 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
France21 sites, 14 recruiting
- Recruiting
CHU
Angers
Sigismond Lasocki
- Recruiting
CHU
Bordeaux
Laurent Petit
- Recruiting
CHU
Bordeaux
Hugues De Courson
- Terminated
CH
Bourg-en-Bresse
- Recruiting
CHU
Caen
Clément Gakuba
- Recruiting
CHU
Clermont-Ferrand
Russell Chabanne
- Completed
CHU
Grenoble
- Recruiting
CHU
La Réunion
Sophie Kauffmann
- Recruiting
CHU
Lille
Natalie De Sa
- Recruiting
Hospices Civils de Lyon
Lyon
Florent Gobert
- Withdrawn
APHM
Marseille
- Recruiting
CHU
Montpellier
Pierre-François Perrigault
- Completed
CHU
Nantes
- Terminated
Pasteur 2 Hospital - University Hospital
Nice
- Recruiting
CHU
Nîmes
Claire Roger
- Recruiting
Fondation Ophtalmologique Adolphe de Rothschild
Paris
Nicolas Engrand
- Recruiting
CHU
Poitiers
Claire Dahyot-Fizelier
- Recruiting
CHU
Rennes
Yoann Launey
- Completed
CHU
Saint-Etienne
- Recruiting
CHU
Toulouse
Thomas Geeraerts
- Terminated
CH
Valence
About this study
Official title: 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.
Read the 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 :
- Deglutition: 3 points if present
- Gag reflex: 4 points if present
- Cough: 4 points if present
- 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
- Mechanical Ventilator Weaning, Acute Brain Injury, Altered Level of Consciousness, Mechanical Ventilation, Airway Control
- Being tested
- Extubation readiness clinical score, Usual Care
- Keywords
- Coma, Intensive care units, Critical care, Stroke, Traumatic brain injury, Anoxic ischemic encephalopathy, Glasgow coma scale
- Medical subject headings
- Brain Injuries, Consciousness Disorders, Coma, Stroke, Brain Injuries, Traumatic, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extubation readiness clinical scoreProcedure or surgery
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 CareProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Clinicians decide whether to extubate or not following usual care in their ICU ventilator weaning protocol Receives: 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 Receives: Procedure: Extubation readiness clinical score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
Extubation failure is defined as a need of reintubation or death in the 5 days (120 hours) following extubation
Measured: From extubation to Day 5 (120 hours) after extubation
Secondary outcomes (14)
Key secondary outcome measure: time to effective extubation
Time from SBT success (enrollment) to successful liberation from mechanical ventilation, defined as the time point at which a patient is alive and free of invasive ventilatory support for more than 5 days (120 hours)
Measured: From enrollment to day 5 (120 hours) after extubation
Invasive mechanical ventilation duration
Period expressed in days during which patients will need invasive mechanical ventilation
Measured: From admission to the end of ICU Stay
Non-invasive mechanical ventilation duration
Period expressed in days during which patients will need non-invasive mechanical ventilation
Measured: From admission to the end of ICU Stay
Reintubation rate in the first 48 hours
Patients needing reintubation during the first 48h post-extubation
Measured: From extubation to Day 2 after extubation (48 hours)
Reintubation rate in ICU
Patients needing reintubation during entire ICU stay
Measured: From extubation to the end of ICU Stay
Post extubation nosocomial pneumonia
Post extubation nosocomial pneumonia is defined as a pulmonary infection after extubation that necessitate antibiotic therapy
Measured: From extubation to the end of ICU stay
Tracheotomy after extubation
Number of patients that necessitate a tracheotomy after extubation failure
Measured: From extubation to the end of ICU Stay
Tracheotomy before extubation
Number of patients that necessitate a tracheotomy after a successful spontaneous breathing trial but before any extubation
Measured: From enrollment to the end of ICU Stay
ICU length of stay
ICU length of stay expressed in days
Measured: From admission to the end of ICU Stay
Hospital length of stay
Hospital length of stay expressed in days
Measured: From admission to the end of Hospital Stay
Mortality in ICU
Deceased patient in each group during ICU stay
Measured: From enrollment to the end of the ICU Stay
Mortality at day 28
Deceased patient in each group at day 28
Measured: From enrollment to Day 28
Mortality at day 90
Deceased patient in each group at day 90
Measured: From enrollment to Day 90
Neurological outcome
Neurological outcome using the Glasgow Outcome Scale Extended
Measured: Day 90 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start9 Feb 2020
- Primary completion13 Feb 2027 (estimated)
- Study completion13 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilator WeaningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped wedge, cluster randomised controlled design
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- ANARLF Network, Direction Générale de l'Offre de Soin (DGOS)
- Responsible party
- Sponsor
- Investigators
- Russell Chabanne, Study director, University Hospital, Clermont-FerrandOlivier Vincent, Principal investigator, University Hospital, GrenobleFlorent Gobert, Principal investigator, Hospices Civils de LyonJérôme Morel, Principal investigator, Centre Hospitalier Universitaire de Saint EtienneMatthieu Jeannot, Principal investigator, CH VALENCEPierre-André Rodié-Talbère, Principal investigator, Nantes University HospitalThomas Geeraerts, Principal investigator, University Hospital, ToulousePierre-François Perrigault, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080440
- Sponsor's protocol ID
- Biper - PhrcIR 2017 Chabanne
- Other IDs
- 2018-A00894-51
- Acronym
- Biper
- Status last verified
- Feb 2025
- First submitted
- 4 Sep 2019
- Last updated
- 24 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing plan : BIPER clinical trial data will be made available upon reasonable request as soon as study publication with deidentified participant data and statistical/analytic code
Publications
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.
PubMed 27749290Chabanne 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.
PubMed 40659406
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score
- ClinicalTrials.gov ID
- NCT04080440
- Acronym / sponsor ID
- Biper / Biper - PhrcIR 2017 Chabanne
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- ANARLF Network, Direction Générale de l'Offre de Soin (DGOS)
- Study start
- 9 Feb 2020 (actual)
- Primary completion
- 13 Feb 2027 (estimated)
- Study completion
- 13 Oct 2027 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Deglutition: 3 points if present
- Gag reflex: 4 points if present
- Cough: 4 points if present
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge, cluster randomised controlled design
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Procedure: Usual CareClinicians decide whether to extubate or not following usual care in their ICU ventilator weaning protocol |
| Extubation readiness clinical score | Experimental | Procedure: Extubation readiness clinical scoreClinicians decide whether to extubate or not following the extubation readiness clinical score as part of their ICU ventilator weaning protocol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 18 to 75 years old
- Neurological stability with no intracranial hypertension with minimal sedation
- Glasgow Coma Scale motor response < 6
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extubation readiness clinical scoreAfter 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. | Procedure or surgery | Extubation readiness clinical score |
| Usual CareAfter 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. | Procedure or surgery | Usual care |
Primary outcome
Extubation failure
Time frame: From extubation to Day 5 (120 hours) after extubation
Extubation failure is defined as a need of reintubation or death in the 5 days (120 hours) following extubation
14 secondary outcomes
Key secondary outcome measure: time to effective extubation
Time frame: From enrollment to day 5 (120 hours) after extubation
Invasive mechanical ventilation duration
Time frame: From admission to the end of ICU Stay
Non-invasive mechanical ventilation duration
Time frame: From admission to the end of ICU Stay
Reintubation rate in the first 48 hours
Time frame: From extubation to Day 2 after extubation (48 hours)
Reintubation rate in ICU
Time frame: From extubation to the end of ICU Stay
Post extubation nosocomial pneumonia
Time frame: From extubation to the end of ICU stay
Tracheotomy after extubation
Time frame: From extubation to the end of ICU Stay
Tracheotomy before extubation
Time frame: From enrollment to the end of ICU Stay
ICU length of stay
Time frame: From admission to the end of ICU Stay
Hospital length of stay
Time frame: From admission to the end of Hospital Stay
Mortality in ICU
Time frame: From enrollment to the end of the ICU Stay
Mortality at day 28
Time frame: From enrollment to Day 28
Mortality at day 90
Time frame: From enrollment to Day 90
Neurological outcome
Time frame: Day 90 after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 27749290Godet 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.
- Derived from this study: PubMed 40659406Chabanne 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.
- Individual participant dataSharing planned: Yes. Data sharing plan : BIPER clinical trial data will be made available upon reasonable request as soon as study publication with deidentified participant data and statistical/analytic code
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Russell Chabanne study director
University Hospital, Clermont-Ferrand
Olivier Vincent principal investigator
University Hospital, Grenoble
Florent Gobert principal investigator
Hospices Civils de Lyon
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extubation readiness clinical score in people with Mechanical Ventilator Weaning and Acute Brain Injury, run by University Hospital, Clermont-Ferrand at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33 4 73 754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation failure (time frame: From extubation to Day 5 (120 hours) after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04080440, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.