Impact of the Inspiratory Cortical Control on the Outcome of the Ventilatory Weaning Test in Patients Intubated in Resuscitation

Study Overview
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Brief Summary
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In case of respiratory distress, patients are intubated to be connected to an artificial respirator to ensure gas exchanges. Before any ventilatory weaning, a breathing test in spontaneous ventilation under artificial nose is practiced. The patient keeps the endotracheal tube but is no longer assisted by the ventilator. Mortality is markedly increased with the prolongation of the weaning period. Despite the presence of all weaning criteria and the success of a breathing test in spontaneous ventilation under artificial nose, failure of extubation occurs in 20% of patients. Experimental application of an additional inspiratory load in awake healthy subjects causes a compensatory increase in respiratory work to maintain effective ventilation, and the subject does not develop hypoventilation. This respiratory drive to breathe has been demonstrated by quantified electroencephalography in inspiratory load tests in the form of pre-inspiratory negative deflections of low amplitude similar to the potential described during the preparation of the voluntary movement of a limb. These inspiratory pre-motor potentials begin about 2.5 seconds before the start of a movement in the additional motor area. Does the simple and noninvasive analysis of inspiratory cortical control during the spontaneous ventilation breath test under artificial nose predict the outcome of this test as well as weaning at 7 days?

Official Title
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Impact of the Inspiratory Cortical Control on the Outcome of the Ventilatory Weaning Test in Patients Intubated in Resuscitation

Conditions
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Respiration Disorder, Respiratory Failure, Weaning Failure, Respiratory Compensation, Respiratory Center Dysfunction

Intervention / Treatment
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* Device: Electroencephalography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All intubated-ventilated patients eligible for an artificial nose breathing test in spontaneous ventilation, according to the physician in charge, and to the protocol of the medical resuscitation service and good clinical practice, at least 18 years of age; intubated-ventilated for at least 24 hours; express consent given by patients or relatives after clear and fair information on the study. Exclusion Criteria: Patients are secondarily excluded from the study only if EEG or pressure monitoring are uninterpretable.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Successful weaning<br>Patients extubated after the success of the breathing test in spontaneous ventilation under artificial nose and always extubated after seven days. | Device: Electroencephalography<br>* Simplified electroencephalography using three electroencephalogram electrodes and two electro-oculogram electrodes for the measurement of central respiratory control through the inspiratory premotor potentials.<br>|
| Experimental: Failure to wean<br>Patients who failed the breathing test in spontaneous ventilation under artificial nose and not extubated or patients extubated after the success of the weaning test in spontaneous ventilation under artificial nose but reintubated within seven days. | Device: Electroencephalography<br>* Simplified electroencephalography using three electroencephalogram electrodes and two electro-oculogram electrodes for the measurement of central respiratory control through the inspiratory premotor potentials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnitude of inspiratory premotor potentials | Amplitude in microvolts of the inspiratory premotor potentials measured during the first 15 minutes of the artificial noses breathing test in patients who successfully passed their ventilatory withdrawal and in patients who failed their withdrawal. | Fifteen minutes |