Respiration Disorder, Respiratory Center Dysfunction, Respiratory Compensation, Respiratory Failure, Weaning Failure
Conditions
Brief summary
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?
Interventions
DEVICEElectroencephalography
Simplified electroencephalography using three electroencephalogram electrodes and two electro-oculogram electrodes for the measurement of central respiratory control through the inspiratory premotor potentials.
Sponsors
Poitiers University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnitude of Inspiratory Premotor Potentials | Fifteen minutes | 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. |
Countries
France
Participant flow
Recruitment details
70 patients included but 62 patients could have been analyzed for technical maters
Participants by arm
| Arm | Count |
|---|---|
| SBT Success 45 patients (73%) succeded the Spontaneous breathing trial | 45 |
| SBT Failure 17 patients (27%) failed the Spontaneous breathing trial | 17 |
| Total | 62 |
Baseline characteristics
| Characteristic | Total | SBT Success | SBT Failure |
|---|---|---|---|
| Age, Continuous | 63 years | 60 years | 70 years |
| Body mass index | 31 kg/m² | 30 kg/m² | 32 kg/m² |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 25 Participants | 20 Participants | 5 Participants |
| Sex: Female, Male Male | 37 Participants | 25 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 17 |
| other Total, other adverse events | 0 / 45 | 0 / 17 |
| serious Total, serious adverse events | 0 / 45 | 0 / 17 |
Outcome results
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.
Time frame: Fifteen minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SBT Success | Magnitude of Inspiratory Premotor Potentials | 1.2 µV |
| SBT Failure | Magnitude of Inspiratory Premotor Potentials | 2.1 µV |