RecruitingNot ApplicableNCT04080440

Brain-injured Patients Extubation Readiness Study

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


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

660 participants

Start Date

Feb 9, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study investigates the best way to decide when to remove a breathing tube (extubate) from brain-injured patients in the ICU who are regaining some consciousness but are not yet fully awake. After a stroke, brain injury, or cardiac arrest, patients often need a mechanical ventilator to breathe for them, and deciding when it is safe to remove the breathing tube is difficult — remove it too early and the patient may fail, too late and complications can arise. This study looks at developing better criteria and protocols for safe extubation in these challenging patients. Brain-injured patients are different from other ICU patients when it comes to extubation because they may be unable to swallow or protect their airway even when their lungs are ready. This study carefully documents what happens to patients in this situation and aims to identify the best predictors of successful extubation. You may be eligible if: - You are aged 18 to 75 years - You have an acute brain injury (stroke, traumatic brain injury, post-cardiac arrest, or brain tumour) requiring ICU admission and mechanical ventilation - You have been on the ventilator for more than 48 hours - You are neurologically stable with minimal sedation - This would be your first extubation attempt - You passed a spontaneous breathing trial You may NOT be eligible if: - Your brain injury is in the posterior cranial fossa - You have a spinal cord injury, uncontrolled seizures, or active CNS infection - You have a chronic respiratory condition (COPD, sleep apnoea requiring CPAP) - You are pregnant or breastfeeding - You have a care limitation plan (e.g., palliation) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREExtubation readiness clinical score

After treatment of the acute neurological condition, eligibility for a spontaneous breathing trial will be assessed once a day. In the intervention group, after a successful spontaneous breathing trial in unconscious patients, the score will be evaluated. If the score is \> 9, extubation has to be completed.

PROCEDUREUsual Care

After treatment of the acute neurological condition, eligibility for a spontaneous breathing trial will be assessed once a day. In the control group, after a successful spontaneous breathing trial in unconscious patients, the extubation will be achieved according to usual care.


Locations(21)

CHU

Angers, France

CHU

Bordeaux, France

CHU

Bordeaux, France

CH

Bourg-en-Bresse, France

CHU

Caen, France

CHU

Clermont-Ferrand, France

CHU

Grenoble, France

CHU

La Réunion, France

CHU

Lille, France

Hospices Civils de Lyon

Lyon, France

APHM

Marseille, France

CHU

Montpellier, France

CHU

Nantes, France

Pasteur 2 Hospital - University Hospital

Nice, France

CHU

Nîmes, France

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

CHU

Poitiers, France

CHU

Rennes, France

CHU

Saint-Etienne, France

CHU

Toulouse, France

CH

Valence, France

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NCT04080440


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