Actively Recruiting
Brain-injured Patients Extubation Readiness Study
Led by University Hospital, Clermont-Ferrand · Updated on 2025-09-24
660
Participants Needed
21
Research Sites
400 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Clermont-Ferrand
Lead Sponsor
A
ANARLF Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Brain-injured Patients Extubation Readiness Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute cerebral lesion with Glasgow Coma Scale less than 13 requiring ICU admission and mechanical ventilation for neurological cause such as stroke, traumatic brain injury, anoxic ischemic encephalopathy, or brain tumor
- Mechanical ventilation for more than 48 hours
- Age between 18 and 75 years
- Neurological stability without intracranial hypertension and minimal sedation
- 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 (tetraplegia or paraplegia)
- Uncontrolled status epilepticus or uncontrolled central nervous system infection
- Care limitation plan in place
- Chronic respiratory failure requiring ambulatory oxygen, pressure support ventilation, proven COPD, or ambulatory CPAP for sleep apnea
- More than 3 failed spontaneous breathing trials
- Significant chest trauma (more than 2 broken ribs or broken sternum requiring surgery)
- Planned surgery within 7 days
- Tracheotomy or previous extubation outside the study protocol
- Previous compromised upper airway
- Pregnant or breastfeeding women
- Adults under legal protection or without social insurance
- Participation in another clinical trial on mechanical ventilation or weaning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
CHU
Angers, France
Actively Recruiting
2
CHU
Bordeaux, France
Actively Recruiting
3
CHU
Bordeaux, France
Actively Recruiting
4
CH
Bourg-en-Bresse, France
Terminated
5
CHU
Caen, France
Actively Recruiting
6
CHU
Clermont-Ferrand, France
Actively Recruiting
7
CHU
Grenoble, France
Completed
8
CHU
La Réunion, France
Actively Recruiting
9
CHU
Lille, France
Actively Recruiting
10
Hospices Civils de Lyon
Lyon, France
Actively Recruiting
11
APHM
Marseille, France
Withdrawn
12
CHU
Montpellier, France
Actively Recruiting
13
CHU
Nantes, France
Completed
14
Pasteur 2 Hospital - University Hospital
Nice, France
Terminated
15
CHU
Nîmes, France
Actively Recruiting
16
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France
Actively Recruiting
17
CHU
Poitiers, France
Actively Recruiting
18
CHU
Rennes, France
Actively Recruiting
19
CHU
Saint-Etienne, France
Completed
20
CHU
Toulouse, France
Actively Recruiting
21
CH
Valence, France
Terminated
Research Team
L
Lise Laclautre
CONTACT
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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