Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT04080440

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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