An interventional study of Electroencephalography in Respiration Disorder, Respiratory Failure and Weaning Failure, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Basic science
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?
Exclusion Criteria:
Patients extubated after the success of the breathing test in spontaneous ventilation under artificial nose and always extubated after seven days.
Device: Electroencephalography
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
Simplified electroencephalography using three electroencephalogram electrodes and two electro-oculogram electrodes for the measurement of central respiratory control through the inspiratory premotor potentials.
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.
Time frame: Fifteen minutes
70 patients included but 62 patients could have been analyzed for technical maters
| Milestone | SBT Success | SBT Failure |
|---|---|---|
| Started | 45 | 17 |
| Completed | 45 | 17 |
| Not completed | 0 | 0 |
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.
| µV | SBT Success | SBT Failure |
|---|---|---|
| Magnitude of Inspiratory Premotor Potentials | 1.2 (0.5 to 2.0) | 2.1 (1.7 to 2.9) |
Collected over from enrollement until the end of the spontaneous breathing trial the same day for the primary objective's mesurement and until 7 days for the whole follow up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SBT Success | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| SBT Failure | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Continuous(years) | SBT Success | SBT Failure | Total |
|---|---|---|---|
| Median | 60 (56 to 67) | 70 (62 to 76) | 63 (57 to 71) |
| Sex: Female, Male(Participants) | SBT Success | SBT Failure | Total |
|---|---|---|---|
| Female | 20 | 5 | 25 |
| Male | 25 | 12 | 37 |
| Race and Ethnicity Not Collected(Participants) | SBT Success | SBT Failure | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Body mass index(kg/m²) | SBT Success | SBT Failure | Total |
|---|---|---|---|
| Median | 30 (26 to 34) | 32 (28 to 34) | 31 (27 to 34) |
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Poitiers University Hospital