Non-medicinal Technique and Dyspnea in Weaning Patients

Launched by HOSPICES CIVILS DE LYON · Apr 7, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a non-medicinal technique called medical hypnosis to help patients in the intensive care unit (ICU) who are having difficulty stopping mechanical ventilation. Specifically, the study aims to see if hypnosis can reduce feelings of breathlessness (dyspnea) before a test called a spontaneous breathing trial (SBT), which is when patients try to breathe on their own without the ventilator. The trial will involve two groups: one that receives standard care and another that receives standard care plus hypnosis. Patients will be monitored daily for up to seven days or until they are taken off the ventilator.

To be eligible for this trial, participants need to be adults who have been on mechanical ventilation for at least 24 hours and have not passed a breathing trial before. Some key exclusions include patients with certain neurological conditions, those with severe psychiatric issues, or anyone who cannot communicate effectively. If chosen to participate, individuals can expect daily sessions that include hypnosis aimed at helping them feel more comfortable while preparing for the breathing trial. This study is still in the planning stages and has not yet started recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.