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

Not Applicable

• Conditions: Respiratory Failure; Respiration Disorder; Weaning Failure; Respiratory Center Dysfunction; Respiratory Compensation
• Interventions: Device: Electroencephalography

• Registration Number: NCT03372252
• Lead Sponsor: Poitiers University Hospital

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-21
• Study First Submitted: 2017-09-23
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-13
• Status Verified: 2019-03
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-10-31
• Primary Completion: 2020-01-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Successful weaning	Electroencephalography	Patients extubated after the success of the breathing test in spontaneous ventilation under artificial nose and always extubated after seven days.
Failure to wean	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

university hospital center of Poitiers; 🇫🇷 Poitiers, Vienne, France