Hypnosis During Mechanical Ventilation Weaning

Официальное название

Hypnosis During Mechanical Ventilation Weaning : Feasibility and Physiological Impact

Обзор

Hypnosis is defined as an altered state of consciousness characterized by an increased susceptibility to suggestion. It is a technique commonly used in the medical field, primarily for the management of pain and anxiety. The literature demonstrates that better pain management is correlated with a shorter length of stay in the ICU and a shorter duration of mechanical ventilation. In patients hospitalized in the ICU requiring invasive mechanical ventilation, the emotional component plays a significant role in dyspnea, which can become an obstacle to weaning from ventilation. The analgesic and anxiolytic treatments used carry numerous side effects and contraindications, limiting their use in ICU patients. Furthermore, pulmonary edema is a common cause of failure to wean from invasive mechanical ventilation. By reducing the occurrence of hypertension and tachycardia, hypnosis could be used as a therapeutic strategy to limit its incidence. Thus, hypnosis could be a valuable therapeutic tool for improving tolerance and the success of ventilator weaning. Although hypnosis is already commonly used in intensive care units, its use is still limited by a lack of evidence for more specific indications. It is in this context that this study was conducted, to assess the feasibility of conducting a hypnosis session during weaning from invasive mechanical ventilation in the intensive care unit.

Вмешательства

• Поведенческое Hypnosis
  The intervention consists of a standardized hypnosis session delivered by a trained practitioner during the weaning phase from invasive mechanical ventilation in an intensive care unit.

Первичные конечные точки

• Feasibility of a hypnosis session during weaning from invasive mechanical ventilation. [Срок оценки: At the end of the recruitment period]

Вторичные конечные точки (7)

• Progression of pain and anxiety during weaning from invasive mechanical ventilation using hypnosis. [Срок оценки: During the hypnosis session (Day 1)]
• Frequency of failed weaning from invasive mechanical ventilation among patients who underwent a hypnosis session. [Срок оценки: During ICU stay]
• Complications associated with weaning from mechanical ventilation using hypnosis. [Срок оценки: During the ICU stay]
• Length of stay in the intensive care unit following weaning from mechanical ventilation using hypnosis. [Срок оценки: ICU stay]
• Mortality following weaning from mechanical ventilation using hypnosis. [Срок оценки: At day 28]
• Patients' experiences [Срок оценки: On the day of discharge from the ICU, and no later than Day 28]
• Professionals' perceptions of hypnosis [Срок оценки: Throughout the study's enrollment period.]

Критерии участия

Критерии включения

• Patients aged 18 and older
• Patients hospitalized in the intensive care unit and requiring invasive mechanical ventilation for at least 48 hours
• Presence of the prerequisite criteria for ventilator weaning: effective cough, minimal bronchial congestion, patient awake and not agitated, hemodynamic stability (heart rate less than 140 beats per minute, systolic blood pressure between 90 and 160 mmHg without vasopressors), pressure support ventilation, FiO2 < 40% and PEEP ≤ 8 cmH2O, PaO2/FiO2 > 150, pH > 7.35, respiratory rate < 35 per minute
• Patients enrolled in a social security program or eligible for such a program
• Patients who has received complete information about the clinical research protocol and has signed an informed consent form
• Patients who has undergone a preliminary clinical examination appropriate for the clinical research

Критерии исключения

• Contraindication to hypnosis (particularly severe psychotic disorders)
• Non-French-speaking individuals
• Deaf or hard-of-hearing individuals
• State of agitation or acute delirium
• Individuals who have already undergone a spontaneous ventilation test or an attempt at orotracheal extubation during their hospitalization
• Individuals receiving a new anxiolytic or sedative treatment within 2 hours prior to the weaning test
• Individuals with a tracheostomy
• Women of childbearing age who do not have access to effective contraception
• Individuals covered by Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the Public Health Code (pregnant women, women in labor, or breastfeeding women, minors not emancipated, adult subject to a legal protection measure, adult unable to give consent)
• Person deprived of liberty by a judicial or administrative decision, or a person receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Central Hospital — Nancy

Идентификаторы

NCT: NCT07518498 · 2025PI107

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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