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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03372252
• Other study ID #: BRAIN-WEAN
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Respiration Disorder
• Respiration Disorders
• Respiratory Center Dysfunction
• Respiratory Compensation
• Respiratory Failure
• Respiratory Insufficiency
• Weaning Failure

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