Non-medicinal Technique and Dyspnea in Weaning Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Protocolized medical hypnosis
BehavioralPatients 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.
Protocolized standard of care
BehavioralThe protocolized standard of care will consist in the description of authorized human/behavioral patient-nurse interactions and patient installation prior to the daily SBT.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Medical hypnosisExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention
Trial outcomes
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.
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 outcomes
1
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.2
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 days3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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