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

NCT03372252 | Completed Results

• 1 other identifier: BRAIN-WEAN
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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?

Conditions

Respiratory Failure; Weaning Failure; Respiratory Compensation; Respiratory Center Dysfunction; Respiration Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Successful weaning

EXPERIMENTAL

Patients extubated after the success of the breathing test in spontaneous ventilation under artificial nose and always extubated after seven days.

Device: Electroencephalography

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.

Device: Electroencephalography

Interventions

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.

Failure to wean; Successful weaning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients are secondarily excluded from the study only if EEG or pressure monitoring are uninterpretable.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

university hospital center of Poitiers

Poitiers, Vienne, 86000, France

Location

MeSH Terms

Conditions

Respiration Disorders; Respiratory Insufficiency

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr RAULT Christophe
• Organization: CHU de Poitiers

christophe.rault@chu-poitiers.fr

0549445348

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2017
• First Posted: December 13, 2017
• Study Start: February 21, 2017
• Primary Completion: January 30, 2020
• Study Completion: July 30, 2020
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2026-01

Locations

FR (1)