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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Successful weaning | Experimental | Patients extubated after the success of the breathing test in spontaneous ventilation under artificial nose and always extubated after seven days. |
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| Failure to wean | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroencephalography | Device | Simplified electroencephalography using three electroencephalogram electrodes and two electro-oculogram electrodes for the measurement of central respiratory control through the inspiratory premotor potentials. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| university hospital center of Poitiers | Poitiers | Vienne | 86000 | France |
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70 patients included but 62 patients could have been analyzed for technical maters
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| ID | Title | Description |
|---|---|---|
| FG000 | SBT Success | 45 patients (73%) succeded the Spontaneous breathing trial |
| FG001 | SBT Failure | 17 patients (27%) failed the Spontaneous breathing trial |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2017 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SBT Success | 45 patients (73%) succeded the Spontaneous breathing trial |
| BG001 | SBT Failure | 17 patients (27%) failed the Spontaneous breathing trial |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Body mass index | Median | Inter-Quartile Range | kg/m² |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | µV | Fifteen minutes |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SBT Success | 45 patients (73%) succeded the Spontaneous breathing trial | 0 | 45 | 0 | 45 | 0 | 45 |
| EG001 | SBT Failure | 17 patients (27%) failed the Spontaneous breathing trial | 0 | 17 | 0 | 17 | 0 | 17 |
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Patients were not consecutively recruited due to the limited availability of investigator/research materials followed by the COVID- 19 pandemic. As a result, this study presents only a fraction of the eligible population. PIP methodology is complex and requires EEG recording and sophisticated EEG signal analysis, which was performed off-line in our study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr RAULT Christophe | CHU de Poitiers | 0549445348 | christophe.rault@chu-poitiers.fr |
| Jan 6, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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