Non-medicinal Technique and Dyspnea in Weaning Patients

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), ventilated with invasive mechanical ventilation for 24 hours or more and having failed a spontaneous breathing trial (SBT, i.e. weaning test of invasive mechanical ventilation \[IMV\]). The primary objective is to evaluate the efficacy of medical hypnosis in reducing dyspnea experienced before the SBT in patients identified as difficult to wean in the ICU, compared with the protocolized standard of care. The primary outcome is the mean value of the daily visual analog scale (VAS) of dyspnea, self-assessed by the patient, measured immediately after the hypnosis session (before SBT) from Day-0 to Day-7 or until extubation. In the control group, the daily value (from D0 to D7 or extubation) of the self-assessed dyspnea VAS will be measured immediately before SBT. The protocol will be divided into two arms: a control arm in which standard of care practices regarding the daily SBT will be protocolized, and an interventional arm in which patients will receive protocolized medical hypnosis before the daily SBT in addition to the protocolized standard of care. The intervention (hypnosis or control) will be performed daily for 7 days (or until extubation, if applicable). The primary outcome will be assessed daily over the same period.

NCT Number	NCT06926231
Lead Sponsor	Hospices Civils de Lyon
Conditions	Difficult Mechanical Ventilation Weaning, Spontaneous Breathing Trial, Dyspnea
Enrollment	82 participants
Start Date	2025-06-01
Primary Completion	2027-06-01 (estimated)
Study Completion	2027-06-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-23