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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03372252
Other study ID # BRAIN-WEAN
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 21, 2017
Est. completion date July 30, 2020

Study information

Verified date March 2019
Source Poitiers University Hospital
Contact xavier Drouot, professor
Phone 0549443465
Email xavier.drouot@chu-poitiers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date July 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
France university hospital center of Poitiers Poitiers Vienne

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
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. Fifteen minutes
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