Hypnosis During Mechanical Ventilation Weaning : Feasibility and Physiological Impact
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of a hypnosis session during weaning from invasive mechanical ventilation.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patients on invasive mechanical ventilation
干预措施: Hypnosis (Behavioral)
结局指标
主要结局
Feasibility of a hypnosis session during weaning from invasive mechanical ventilation.
时间窗: At the end of the recruitment period
Number of hypnosis sessions conducted, relative to the number of eligible patients.
次要结局
- Progression of pain and anxiety during weaning from invasive mechanical ventilation using hypnosis.(During the hypnosis session (Day 1))
- Frequency of failed weaning from invasive mechanical ventilation among patients who underwent a hypnosis session.(During ICU stay)
- Complications associated with weaning from mechanical ventilation using hypnosis.(During the ICU stay)
- Length of stay in the intensive care unit following weaning from mechanical ventilation using hypnosis.(ICU stay)
- Mortality following weaning from mechanical ventilation using hypnosis.(At day 28)
- Patients' experiences(On the day of discharge from the ICU, and no later than Day 28)
- Professionals' perceptions of hypnosis(Throughout the study's enrollment period.)
研究者
Gibot Sébastien
Professor
Central Hospital, Nancy, France