NCT04529395已完成不适用
Impact of Aromatherapy on the Delirium of Patients in Intensive Care Unit
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace2 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2020年9月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Occurrence of delirium
研究概览
简要总结
The primary objective of this monocenter randomized controlled trial is to assess the efficacy of aromatherapy to prevent delirium in patients hospitalized in an intensive care unit.
详细描述
Secondary objectives:
- To assess the efficacy of aromatherapy on :
- the level of consciousness,
- pain,
- the duration of mechanical ventilation,
- the occurence of an accidental extubation,
- the length of stay in the intensive care unit,
- the cumulative duration of delirium episodes,
- the time until first episode of delirium,
- the use of neuroleptics.
- To determine the factors influencing the efficacy of aromatherapy.
- To assess the safety of aromatherapy.
Conduct of research:
After inclusion, patients will be randomized between the aromatherapy and control groups. Treatment will be started on the same day as randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years old
- •Patient hospitalized in an intensive care unit for an expected duration of at least 24 hours
- •Patient requiring mechanical ventilation with initial therapeutic sedation adapted secondarily for comfort sedation, defined by a RASS score target between -2 and 0
- •Patient affiliated to/beneficiary of a social security scheme
排除标准
- •Allergy to essential and/or vegetable oils
- •Palliative sedation
- •Foot skin injury contraindicating the application of an oil
- •Moribund patient or expected death
- •History of dementia
- •Participation to a RIPH-1 study
- •Pregnant or breastfeeding woman
- •Patient under legal protection
- •Patient deprived of liberty by judicial or administrative decision
结局指标
主要结局
Occurrence of delirium
时间窗: Up to 15 days after randomization
The occurrence of delirium will be defined by the presence of at least one episode during the patient's stay in the intensive care unit, diagnosed using the CAM-ICU scale.
次要结局
- Score on the Behavior-Pain Scale(Up to 15 days after randomization)
- Score on the Richmond Agitation-Sedation Scale(Up to 15 days after randomization)
- Length of stay in intensive care unit(Up to 15 days after randomization)
- Cumulative duration of delirium episodes(Up to 15 days after randomization)
- Duration of neuroleptic treatment(Up to 15 days after randomization)
- Occurrence of at least one accidental extubation during the stay(Up to 15 days after randomization)
- Time until first episode of delirium(Up to 15 days after randomization)
- Occurrence of a local allergic reaction(Up to 15 days after randomization)
- Duration of mechanical ventilation between admission and first extubation(Up to 15 days after randomization)
研究者
研究点 (2)
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