NCT04220463招募中不适用
HYVIR : Interest of Hypnosis During the Implementation of Non-invasive Ventilation in a Patient With COPD and/or Obesity With a BMI Greater Than 30, Conscious With Acute Respiratory Distress in the Adult Intensive Care Unit
Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年11月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Comfort
研究概览
简要总结
Discomfort during respiratory decompensation of a patient with chronic obstructive pulmonary disease (COPD) and/or obesity with a BMI greater than 30, in intensive care and the establishment of non-invasive ventilation (NIV) is frequent and a source of failure. this therapy. Pharmacological treatments may be impossible due to the pathology, the risk of it worsening and adverse effects. In this context, hypnosis appears to be a tool that would promote comfort and thus increase tolerance of NIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patient randomization will be done online.
SETTING UP AND MAINTAINING THE INSU People having knowledge of the randomization group
- Doctor in charge of the patient
- Doctor/IDE dedicated to hypnosis (present throughout the procedure, regardless of the randomization group)
- Patient People not having knowledge of the randomization group
- assessor = other IDE or doctor not directly taking care of the patient assessor present at 4 times: inclusion, H0, H2 and H24 but absent during the procedure 1 single assessor for the 4 times of the same patient
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
- •Pre-inclusion criteria
- •Man or woman, aged 18 or over, admitted to medical intensive care
- •Glasgow score = 15
- •Patient with acute respiratory failure decompensating COPD and/or having obesity with a body mass index (BMI) greater than 30
- •Patient having given free, informed and written consent
- •Patient affiliated to a health insurance system
- •Inclusion Criteria:
- •Glasgow score = 15
- •Need during use of non-invasive ventilation
排除标准
- •Procedure to be carried out in extreme urgency (PaCO2 too high and leading to an immediate vital risk, and / or PaO2 too low) on medical decision
- •Confusional state making hypnosis impossible
- •Decompensated psychiatric illness
- •Patient entering with an NIV in place already installed in another department. The subject becomes included again at the end of the treatment with NIV if however he needs it again.
- •Patient already included in the study during previous non-invasive ventilation
- •Patient participating in research involving an interventional human person (category 1) on an analgesic / sedative medication
- •A person of full age subject to legal protection (safeguard of justice, curators, guardianship) or deprived of liberty
结局指标
主要结局
Comfort
时间窗: 2 hours after initiation of NIV
Quantification of comfort by a Digital Verbal Comfort Scale 2 hours after initiation of NIV (from 0 to 10, 0 being the minimum comfort felt and 10 the maximum comfort felt by the patient)
次要结局
- Comfort(Before and 30 minuts and 24 hours after the implementation of the NIV)
- TcpCO2(Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV)
- NIV duration(after the first 24 hours of treatment)
- First NIV session duration(At the end of the first NIV session)
- Intubation(Day 28)
- anxiolytic treatment prescription(Day 28)
- Anxiety(Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV)
- dyspnea(2 hours after the setting up of the NIV)
- stress(Before and 30 minuts and 2 hours after the implementation of the NIV)
- Stay duration(Day 28)
研究者
研究点 (2)
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