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

P

Poitiers University Hospital

Status

Completed

Conditions

Weaning Failure
Respiratory Center Dysfunction
Respiratory Failure
Respiratory Compensation
Respiration Disorder

Treatments

Device: Electroencephalography

Study type

Interventional

Funder types

Other

Identifiers

NCT03372252
BRAIN-WEAN

Details and patient eligibility

About

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?

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Successful weaning
Experimental group
Description:
Patients extubated after the success of the breathing test in spontaneous ventilation under artificial nose and always extubated after seven days.
Treatment:
Device: Electroencephalography
Failure to wean
Experimental group
Description:
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.
Treatment:
Device: Electroencephalography

Trial documents
1

Trial contacts and locations

1

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Central trial contact

xavier Drouot, professor

Data sourced from clinicaltrials.gov

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