An interventional study of Protocolized medical hypnosis and Protocolized standard of care in Difficult Mechanical Ventilation Weaning, Spontaneous Breathing Trial and Dyspnea, sponsored by Hospices Civils de Lyon. Not yet recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Supportive care
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's planned enrollment of 82 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
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Exclusion Criteria:
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
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
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.
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.
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.
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.
Mean MV-RDOS score (Mechanical Ventilation-Respiratory Distress Observation Scale) after the intervention or the control strategy
The outcome is a scale evaluating respiratory distress assessed by the treating team, as a reliable surrogate of self-reported dyspnea in non-communicative intubated patients The minimum and maximum values are 0 and 16. An RDOS score of less than 3 indicates respiratory comfort; An RDOS score greater than or equal to 3 signifies respiratory distress and need for palliation Higher RDOS scores signify a worsening condition The outcome measure consists in the mean value of the daily measures collected during this period.
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
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 SBT protocol lasts 30 minutes at the end of which the dyspnea VAS will be evaluated. The outcome measure consists in the mean value of the daily measures collected during this period.
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
The outcome is a scale evaluating respiratory distress assessed by the treating team, as a reliable surrogate of self-reported dyspnea in non-communicative intubated patients The minimum and maximum values are 0 and 16. An RDOS score of less than 3 indicates respiratory comfort; An RDOS score greater than or equal to 3 signifies respiratory distress and need for palliation Higher RDOS scores signify a worsening condition The SBT protocol lasts 30 minutes at the end of which the MV-RDOS will be evaluated. The outcome measure consists in the mean value of the daily measures collected during this period.
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
Mean value of self-reported daily visual analog scale (VAS) of anxiety, 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 anxiety will be measured immediately before SBT. The SBT protocol lasts 30 minutes at the end of which the anxiety VAS will be evaluated. The outcome measure consists in the mean value of the daily measures collected during this period.
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
Mean value of self-reported daily visual analog scale (VAS) of pain, 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 pain will be measured immediately before SBT. The SBT protocol lasts 30 minutes at the end of which the pain VAS will be evaluated.
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
Respiratory rate (in bpm, beats per minute) and O2 percutaneous saturation (in %)
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
Heart rate (in bpm) and mean arterial pressure (in mmHg / millimetre of mercury)
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
Rate of medical hypnosis sessions and standard of care sessions in each group achieving predefined quality criteria. Predefined quality criteria are: interruption, quality of the interaction, duration of the intervention, impossibility to apply the strategy, adverse event
Time frame: Up to Day 7
Feasibility: enrolment
Number of subjects included divided by total number of eligible subjects
Time frame: At the end of the study recruitment.
Feasibility: hypnosis training
Number of hypnosis training sessions for paramedics of participating centers actually carried out in participating centers during the study.
Time frame: At the end of the recruitment.
Safety: neurological impact of strategies
Highest value of the Richmond Agitation Sedation Scale (-5 to +4) observed daily during the hypnosis session or control intervention.
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
Ventilator free days (VFD) : number of days alive without invasive mechanical ventilation, between the date of last successful extubation and day 28. A score of 0 is allocated in case of death between inclusion and day 28.
Time frame: Measured at day 28
Reintubation
Rate of reintubation within 7 days of extubation, until day 28.
Time frame: Measured at day 28
ICU length of stay
Number of days between randomization and ICU discharge.
Time frame: through study completion, up to 28 days
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon