Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID04080440

Stepped Wedge Cluster Randomised Controlled Trial to Assess Extubation Readiness in Brain-injured Patients Using a Clinical Score

Led by University Hospital, Clermont-Ferrand · Updated on 2025-09-24

660

Participants Needed

21

Research Sites

34 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

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 75 years
  • 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
Not Eligible

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

AI-Screening

AI-Powered Screening

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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

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

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

Extubation Failure in Brain-injured Patients: Risk Factors and Development of a Prediction Score in a Preliminary Prospective Cohort Study.

Thomas Godet, Russell Chabanne, Julien Marin...

https://pubmed.ncbi.nlm.nih.gov/27749290

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...

https://pubmed.ncbi.nlm.nih.gov/40659406