Non-medicinal Technique and Dyspnea in Weaning Patients

Official title

Impact of a Non-medicinal Technique Medical Hypnosis on Perceived Dyspnea in Difficult Ventilatory Weaning Patients: a Multicenter Randomized Controlled Trial.

Overview

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.

Interventions

• Behavioral 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
• 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.

Primary outcome measures

• Mean value of self-reported daily visual analog scale of dyspnea after the intervention or the control strategy [Time frame: 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 outcome measures (12)

• Mean MV-RDOS score (Mechanical Ventilation-Respiratory Distress Observation Scale) after the intervention or the control strategy [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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.]
• Respiratory physiology [Time frame: Value of respiratory rate and SpO2, measured immediately at the beginning of the SBT, and worst value observed during the daily SBT, between inclusion and day 7 or extubation]
• Hemodynamic status [Time frame: Value of heart rate and mean arterial pressure, measured immediately at the beginning of the SBT, and worst value observed during the daily SBT, between inclusion and day 7 or extubation]
• Quality of applied intervention and control strategies [Time frame: Up to Day 7]
• Feasibility: enrolment [Time frame: At the end of the study recruitment.]
• Feasibility: hypnosis training [Time frame: At the end of the recruitment.]
• Safety: neurological impact of strategies [Time frame: The RASS value will be assessed continuously during the duration of the intervention in Gp1 or during the protocolized observation period in Gp2, and its highest value will be reported. It will be reported daily in each group, between inclusion and D7.]
• Invasive mechanical ventilation weaning [Time frame: Measured at day 28]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

France · 5 centers

• Hôpital de Fleyriat - Centre hospitalier de Bourg-en-Bresse - Réanimation Soins continus — Bourg-en-Bresse
• CHU Clermont Ferrand - Hôpital Gabriel Montpied - Médecine Intensive Réanimation — Clermont-Ferrand
• CHU Grenoble Alpes - Hôpital Michallon - Médecine Intensive Réanimation — La Tronche
• Hospices Civils de Lyon - Hôpital de la Croix Rousse - Médecine Intensive Réanimation — Lyon
• Hospices Civils de Lyon - Hôpital Lyon Sud - Réanimation Polyvalente — Pierre-Bénite

Identifiers

NCT: NCT06926231 · 69HCL24_0209 · ID-RCB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗