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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

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Feb 2017, registered Sep 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 29 studies in Respiration Disorders with a site in France — 4 open to participants now, 7 under way, none of them phase 3. Respiration Disorders · France.

Enrollment
10th of 19
70 · median 70
Started
2017
with 3 others
No phase
12 of 29
3 open now
Registered
9th of 29
by date

Among the 29 studies in Respiration Disorders with a site in France, this one is the 10th largest by enrollment of the 19 interventional ones that give a count, is one of 4 that started in 2017, is one of 12 with no phase, and was the 9th registered.

Respiration Disorders

359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.

Browse Respiration Disorders studies →

Open to participants now

4 of the 29 studies in Respiration Disorders with a site in France are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 45 Respiration Disorders studies recruiting now, 27 (60%) set no upper age limit and 13 (29%) stop at 75 or younger; 15 take children under 18; 21 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

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?

03

Conditions studied

  • Respiration Disorder
  • Respiratory Failure
  • Weaning Failure
  • Respiratory Compensation
  • Respiratory Center Dysfunction
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
05

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.

06

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

07

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)
08

Study locations

1 site
  • university hospital center of Poitiers
    Poitiers, Vienne 86000, France
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Jan 2020, 35 months.

Results were first posted in Jan 2026, 5 years 11 months after primary completion.

Of 91 non-industry interventional studies with no phase under Respiration Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 35 months is above that.

Counting every sponsor, half of 111 studies reached it within 18 months; a quarter within 7 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2017
First posted
Dec 13, 2017
StartActual
Feb 21, 2017
Primary completionActual
Jan 30, 2020
CompletionActual
Jul 30, 2020
Results first posted
Jan 7, 2026
Last update
Jan 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03372252
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 ↗

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

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