Non-medicinal Technique and Dyspnea in Weaning Patients (Easy Wean)

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Difficult Mechanical Ventilation Weaning; Spontaneous Breathing Trial; Dyspnea

Treatments: Behavioral: Protocolized medical hypnosis; Behavioral: Protocolized standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT06926231

ID-RCB (Other Identifier)

69HCL24_0209

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Medical hypnosis

Experimental group

Description:

Patients who will receive protocolized medical hypnosis before the SBT every day between inclusion and day-7. Medical hypnosis sessions will consist in the administration of a 5-min hypnotic text by a loudspeaker installed in the ICU room, after selection of a hypnotic theme (sea, mountain or animals) by the participant. The hypnosis session will involve an induction phase, a suggestion phase and an emergence phase, along with self-hypnosis tips. The hypnosis session will immediately precede the SBT (\<2h). The intervention is administered before the SBT daily from the randomization to day 7 or until extubation.

Treatment:

Behavioral: Protocolized medical hypnosis

Standard of care

Active Comparator group

Description:

Patients who will receive protocolized standard of care (without medical hypnosis) before the SBT, every day between inclusion and day 7.

Treatment:

Behavioral: Protocolized standard of care