Trial to Improve Extubation Timing in Brain-Injured Patients
Using a Clinical Score to Reduce Extubation Failure
in Adults Aged 18 to 75 on Mechanical Ventilation
Led by University Hospital, Clermont-Ferrand · Updated on 2025-09-24
660
Participants Needed
21
Research Sites
34 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to reduce extubation failure in critically ill patients with acute brain injuries who have impaired consciousness. These patients often require mechanical ventilation with tracheal intubation, and after their acute neurological condition is treated, doctors need to carefully wean them off ventilators to avoid complications like pneumonia. Current guidelines for ventilator weaning do not include brain-injured patients with impaired consciousness, so this study evaluates a simple clinical score to help decide when to safely remove the breathing tube.
Participants will be assigned by random clusters of intensive care units to receive either usual care or care guided by the extubation readiness clinical score. After a successful spontaneous breathing trial, clinicians in the intervention group will use the score based on swallowing, gag reflex, cough, and consciousness level to decide on extubation. If the score is above 9, extubation should proceed. Those in the usual care group will follow standard ICU ventilator weaning protocols. The study uses a stepped wedge cluster randomized design.
During the study, patients are assessed daily for readiness to breathe without the ventilator. Researchers will monitor extubation failure from the time of extubation up to five days later. They will also track other outcomes such as time to extubation, duration of mechanical ventilation, reintubation rates, pneumonia occurrence, hospital stay length, and neurological outcomes up to 90 days. This thorough evaluation helps understand how the score may improve the timing and success of extubation in this vulnerable group.
CONDITIONS
Brief Title
Brain-injured Patients Extubation Readiness Study
Research Team
L
Lise Laclautre
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Acute cerebral lesion with Glasgow Coma Scale less than 13 requiring ICU admission and mechanical ventilation for neurological reasons
Mechanical ventilation for more than 48 hours
Stable neurological condition with minimal sedation and no intracranial hypertension
Glasgow Coma Scale motor response less than 6
Successful spontaneous breathing trial
First attempt at extubation
You will not qualify if you...
Posterior cranial fossa lesion
Admission for status epilepticus or central nervous system infection
Spinal cord injury causing tetraplegia or paraplegia
Uncontrolled status epilepticus or central nervous system infection
Care limitation plan in place
Chronic respiratory failure requiring ambulatory oxygen or pressure support ventilation, or diagnosed COPD or sleep apnea therapy
More than three failed spontaneous breathing trials
Significant chest trauma needing surgery
Surgery planned within 7 days
Tracheotomy or previous extubation outside protocol
Compromised upper airway
Pregnant or breastfeeding women
Adults under legal protection or without social insurance
Participation in another mechanical ventilation or weaning clinical study
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of mechanical ventilation until extubation
Participants receive mechanical ventilation and undergo daily assessments for eligibility for a spontaneous breathing trial. After a successful trial, participants are extubated either following usual care or guided by the extubation readiness clinical score.
Daily visits for breathing trial assessment until extubation
Follow-up
Duration - Up to 5 days after extubation
Participants are monitored for extubation success and any complications such as reintubation or pneumonia for up to 5 days after extubation.
Daily visits for up to 5 days post-extubation
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
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.
Russell Chabanne, Thomas Godet, Benjamin Andanson...