Non-medicinal Technique and Dyspnea in Weaning Patients

NCT06926231 | Not Yet Recruiting

• 2 other identifiers: 69HCL24_0209ID-RCB
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Difficult Mechanical Ventilation Weaning; Spontaneous Breathing Trial; Dyspnea

Keywords

difficult mechanical ventilation weaning; dyspnea; mechanical ventilation; spontaneous breathing trial; hypnosis

Outcome Measures

Primary Outcomes (1)

• Mean value of self-reported daily visual analog scale of dyspnea after the intervention or the control strategy

  Mean value of self-reported daily visual analog scale (VAS) of dyspnea, 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 day 0 to day 7 or extubation) of self-reported VAS of dyspnea will be measured immediately before SBT. The outcome measure consists in the mean value of the daily measures collected during this period.

  Immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of self-reported VAS of dyspnea will be measured immediately before SBT.

Secondary Outcomes (14)

• Mean MV-RDOS score (Mechanical Ventilation-Respiratory Distress Observation Scale) after the intervention or the control strategy

  Immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of MV-RDOS will be measured immediately before SBT.

• Mean VAS of dyspnea at the end of the SBT

  Immediately at the end of the daily protocolized SBT, which is performed every day from day 0 to day 7 or until extubation in all patients. Measured daily at the end of the SBT, from day 0 to day 7 or until extubation. Up to 28 days

• Mean MV-RDOS at the end of SBT

  Immediately at the end of the daily protocolized SBT, which is performed every day from day 0 to day 7 or until extubation in all patients.

• Mean VAS of anxiety at the end of SBT

  Immediately at the end of the daily protocolized SBT, which is performed every day from day 0 to day 7 or until extubation in all patients.

• Mean VAS of pain at the end of SBT

  Immediately at the end of the daily protocolized SBT, which is performed every day from Day 0 to Day 7 or until extubation in all patients. The outcome measure consists in the mean value of the daily measures collected during this period.

Study Arms (2)

Medical hypnosis

EXPERIMENTAL

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.

Behavioral: Protocolized medical hypnosis

Standard of care

ACTIVE COMPARATOR

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

Behavioral: Protocolized standard of care

Interventions

Protocolized medical hypnosis 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.

Medical hypnosis

Protocolized standard of care 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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (5)

Hôpital de Fleyriat - Centre hospitalier de Bourg-en-Bresse - Réanimation Soins continus

Bourg-en-Bresse, 01012, France

Location

CHU Clermont Ferrand - Hôpital Gabriel Montpied - Médecine Intensive Réanimation

Clermont-Ferrand, 6300, France

Location

CHU Grenoble Alpes - Hôpital Michallon - Médecine Intensive Réanimation

La Tronche, 38700, France

Location

Hospices Civils de Lyon - Hôpital de la Croix Rousse - Médecine Intensive Réanimation

Lyon, 69004, France

Location

Hospices Civils de Lyon - Hôpital Lyon Sud - Réanimation Polyvalente

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christelle TOMBALIAN

CONTACT

+ 33 4 26 10 92 65; ghn.easywean@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-04

Locations

FR (5)