Non-medicinal Technique and Dyspnea in Weaning Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Protocolized medical hypnosis
- Protocolized standard of care
Treatment groups
82 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov