Non-medicinal Technique and Dyspnea in Weaning Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Difficult Mechanical Ventilation Weaning Spontaneous Breathing Trial Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Medical hypnosis

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.

Group Type EXPERIMENTAL

Protocolized medical hypnosis

Intervention Type BEHAVIORAL

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.

Standard of care

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

Group Type ACTIVE_COMPARATOR

Protocolized standard of care

Intervention Type BEHAVIORAL

The protocolized standard of care will consist in the description of authorized human/behavioral patient-nurse interactions and patient installation prior to the daily SBT.

Interventions

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Protocolized medical hypnosis

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.

Intervention Type BEHAVIORAL

Protocolized standard of care

The protocolized standard of care will consist in the description of authorized human/behavioral patient-nurse interactions and patient installation prior to the daily SBT.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No