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

Primary Purpose

Respiration Disorder, Respiratory Failure, Weaning Failure

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroencephalography
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Respiration Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • university hospital center of PoitiersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Successful weaning

Failure to wean

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2017
Last Updated
October 30, 2019
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03372252
Brief Title
Impact of the Inspiratory Cortical Control on the Outcome of the Ventilatory Weaning Test in Patients Intubated in Resuscitation
Official Title
Impact of the Inspiratory Cortical Control on the Outcome of the Ventilatory Weaning Test in Patients Intubated in Resuscitation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration Disorder, Respiratory Failure, Weaning Failure, Respiratory Compensation, Respiratory Center Dysfunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Successful weaning
Arm Type
Experimental
Arm Description
Patients extubated after the success of the breathing test in spontaneous ventilation under artificial nose and always extubated after seven days.
Arm Title
Failure to wean
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Electroencephalography
Intervention Description
Simplified electroencephalography using three electroencephalogram electrodes and two electro-oculogram electrodes for the measurement of central respiratory control through the inspiratory premotor potentials.
Primary Outcome Measure Information:
Title
Magnitude of inspiratory premotor potentials
Description
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.
Time Frame
Fifteen minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xavier Drouot, professor
Phone
0549443465
Email
xavier.drouot@chu-poitiers.fr
Facility Information:
Facility Name
university hospital center of Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Drouot, Professor
Phone
0549443465
Email
xavier.drouot@chu-poitiers.fr

12. IPD Sharing Statement

Learn more about this trial

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

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