CClinicalTrials.gg
CompletedNCT03372252Updated Jan 7, 2026Results posted

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

An interventional study of Electroencephalography in Respiration Disorder, Respiratory Failure and Weaning Failure, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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?

02

Conditions studied

  • Respiration Disorder
  • Respiratory Failure
  • Weaning Failure
  • Respiratory Compensation
  • Respiratory Center Dysfunction
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients are secondarily excluded from the study only if EEG or pressure monitoring are uninterpretable.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Successful weaning

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

    Device: Electroencephalography

  • Experimental
    Failure to wean

    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

  • DeviceElectroencephalography

    Simplified electroencephalography using three electroencephalogram electrodes and two electro-oculogram electrodes for the measurement of central respiratory control through the inspiratory premotor potentials.

05

What researchers measure

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.

    Time frame: Fifteen minutes

06

Results

Posted Jan 7, 2026
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.

Participant flow

70 patients included but 62 patients could have been analyzed for technical maters

Participant flow — Overall Study
MilestoneSBT SuccessSBT Failure
Started4517
Completed4517
Not completed00

Outcome measures

PrimaryMagnitude 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.

Time frame:
Fifteen minutes
Reported as:
Median · µV
Magnitude of Inspiratory Premotor Potentials
µVSBT SuccessSBT Failure
Magnitude of Inspiratory Premotor Potentials1.2 (0.5 to 2.0)2.1 (1.7 to 2.9)

Adverse events

Collected over from enrollement until the end of the spontaneous breathing trial the same day for the primary objective's mesurement and until 7 days for the whole follow up.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SBT Success0/45 (0%)0/45 (0%)0/45 (0%)
SBT Failure0/17 (0%)0/17 (0%)0/17 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)SBT SuccessSBT FailureTotal
Median60 (56 to 67)70 (62 to 76)63 (57 to 71)
Sex: Female, Male
Sex: Female, Male(Participants)SBT SuccessSBT FailureTotal
Female20525
Male251237
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)SBT SuccessSBT FailureTotal
Count of participants——0
Body mass index
Body mass index(kg/m²)SBT SuccessSBT FailureTotal
Median30 (26 to 34)32 (28 to 34)31 (27 to 34)
07

Study locations

1 site
  • university hospital center of Poitiers
    Poitiers, Vienne 86000, France
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 7, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03372252
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Dec 13, 2017
Start date
Feb 21, 2017
Primary completion
Jan 30, 2020
Completion
Jul 30, 2020
Results posted
Jan 7, 2026
Last update
Jan 7, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion