M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- sedative drug consumption in mechanically ventilated ICU patients
研究概览
简要总结
Major objective: a three-days interventional cross-over trial [one day music on, one day wash-out, one day music off][two periods of listening/day], to evaluate:
- Impact on sedative drug consumption.
- Alteration of stress neuropeptide blood concentrations.
Population: mechanically-ventilated ICU patients
The investigators hypothesize the music will decrease the need of sedative drugs and reduce the concentration of neuropeptides in circulation.
详细描述
The study will imply patients mechanically ventilated for more than 3 days, that require sedation with benzodiazepine and narcotics.
There will be two groups both of exposed to music and placebo (headphones without music). The study will be simple blind.
Sedation scale will be followed regularly. Vitals signs and adjustment of sedation will be recorded by the nurse on the ward. Blood test will be taken before and after placement of headphones in the morning. We will measure IL-6, cortisol, copeptin, prolactin, CRP.
We will analyse the total reduction dose of sedation and analgesia on a daily basis. We will consider a fall of 20% of medication to be significative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •adults older than 18 years old
- •expected time of mechanical ventilation of more than 72 hours
- •sedation needs for a scale of Sedation-Agitation Scale (SAS) more than 1
排除标准
- •hearing impairment
- •pregnancy
- •needs of vasopressin
- •needs of curarisation
结局指标
主要结局
sedative drug consumption in mechanically ventilated ICU patients
时间窗: 3 days
次要结局
- stress neuropeptide blood content evolution with MUSIC listening(3 days)