Status:
NOT_YET_RECRUITING
Non-medicinal Technique and Dyspnea in Weaning Patients
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Difficult Mechanical Ventilation Weaning
Spontaneous Breathing Trial
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized, controlled, multicenter, open-label, category 2, parallel-arm study of efficacy and superiority. The target population are patients hospitalized in the intensive care unit (ICU)...
Eligibility Criteria
Inclusion
- Adult patient
- hospitalized in the intensive care unit
- receiving invasive mechanical ventilation for 24 hours or more.
- who has failed at least one spontaneous breathing trial
Exclusion
- Patient already intubated during current ICU stay (including transfer from another ICU unit), with successful extubation during stay.
- Tracheostomized patient or patient with a short-term tracheostomy project.
- Patients with chronic neuromuscular pathologies (myopathy, amyotrophic lateral sclerosis, multi-system atrophy, non-exhaustive list).
- Patient no longer eligible for SBT at time of inclusion (hemodynamic, neurological or respiratory criterion)
- Psychiatric pathology identified in the medical record, diagnosed by a psychiatrist and for which medication is prescribed (bipolar disorder, schizophrenia, anxiety-depressive disorder, non-exhaustive list).
- Recent brain injury, within \< 3 months (stroke, cardiopulmonary arrest with neurological prognosis, non-exhaustive list) objectivated by medical imagery.
- Cognitive impairment or delirium associated with resuscitation, identified by a positive CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) test (dynamic parameter).
- Ocular Glasgow score lower than 4/4 and motor response lower than response to simple commands.
- Delirium tremens with Cushman score \> 7 (dynamic parameter).
- Language barrier, patient who does not use French in everyday life.
- Deaf or hearing-impaired patients.
- Re-sedated patient following the failed SBT the day before inclusion.
- Pregnant, parturient or breastfeeding women, objectified by a negative pregnancy test in women of childbearing age.
- Patient for whom a limitation of therapeutics has been decided, including the absence of a re-intubation project.
- Patient whose consent cannot be obtained (directly or in front of a relative or witness).
- Patient already included in the same study or in another study sharing the same primary outcome.
- Patient deprived of liberty by judicial or administrative decision.
- Patient of legal age under legal protection (guardianship, curators).
- Patient not affiliated to a social security system or beneficiary of a similar system.
- Patient participating in another interventional research study with an exclusion period still in effect at pre-inclusion.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06926231
Start Date
June 1 2025
End Date
June 1 2027
Last Update
May 23 2025
Active Locations (5)
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1
Hôpital de Fleyriat - Centre hospitalier de Bourg-en-Bresse - Réanimation Soins continus
Bourg-en-Bresse, France, 01012
2
CHU Clermont Ferrand - Hôpital Gabriel Montpied - Médecine Intensive Réanimation
Clermont-Ferrand, France, 6300
3
CHU Grenoble Alpes - Hôpital Michallon - Médecine Intensive Réanimation
La Tronche, France, 38700
4
Hospices Civils de Lyon - Hôpital de la Croix Rousse - Médecine Intensive Réanimation
Lyon, France, 69004