An interventional study of Extubation readiness clinical score and Usual Care in Mechanical Ventilator Weaning, Acute Brain Injury and Altered Level of Consciousness, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 21 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Supportive care
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.
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 :
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.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 660 is above the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinicians decide whether to extubate or not following usual care in their ICU ventilator weaning protocol
Procedure: Usual Care
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
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.
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 failure
Extubation failure is defined as a need of reintubation or death in the 5 days (120 hours) following extubation
Time frame: From extubation to Day 5 (120 hours) after extubation
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)
Time frame: 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
Time frame: 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
Time frame: From admission to the end of ICU Stay
Reintubation rate in the first 48 hours
Patients needing reintubation during the first 48h post-extubation
Time frame: From extubation to Day 2 after extubation (48 hours)
Reintubation rate in ICU
Patients needing reintubation during entire ICU stay
Time frame: 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
Time frame: From extubation to the end of ICU stay
Tracheotomy after extubation
Number of patients that necessitate a tracheotomy after extubation failure
Time frame: 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
Time frame: From enrollment to the end of ICU Stay
ICU length of stay
ICU length of stay expressed in days
Time frame: From admission to the end of ICU Stay
Hospital length of stay
Hospital length of stay expressed in days
Time frame: From admission to the end of Hospital Stay
Mortality in ICU
Deceased patient in each group during ICU stay
Time frame: From enrollment to the end of the ICU Stay
Mortality at day 28
Deceased patient in each group at day 28
Time frame: From enrollment to Day 28
Mortality at day 90
Deceased patient in each group at day 90
Time frame: From enrollment to Day 90
Neurological outcome
Neurological outcome using the Glasgow Outcome Scale Extended
Time frame: Day 90 after enrollment
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Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
Started Feb 2020 (actual). Primary completion is estimated for Feb 2027, 84 months after the start.
Of 284 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 84 months is above that.
Counting every sponsor, half of 297 studies reached it within 24 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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