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/27749290Actively Recruiting
Led by University Hospital, Clermont-Ferrand · Updated on 2025-09-24
660
Participants Needed
21
Research Sites
34 weeks
Total Duration
U
University Hospital, Clermont-Ferrand
Lead Sponsor
A
ANARLF Network
Collaborating Sponsor
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
Brain-injured Patients Extubation Readiness Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
L
Lise Laclautre
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Thomas Godet, Russell Chabanne, Julien Marin...
https://pubmed.ncbi.nlm.nih.gov/27749290Russell Chabanne, Thomas Godet, Benjamin Andanson...
https://pubmed.ncbi.nlm.nih.gov/40659406