NCT06346119招募中不适用
Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- chemical restraint
研究概览
简要总结
This is a randomized prospective study. This objective is the impact of "relaxing touch" on the use of chemical restraint for patients in intensive care from the lifting of sedation until extubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
It's a person external to the care service and to the randomization process will collect the possible prescription of a chemical restraint or the evolution of this chemical restraint by the resuscitator, in order to maintain the blind.
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
- •Male or female over 18 years of age
- •Intubated and sedated man or woman
- •Extubation within 48 hours
- •Intubation of more than 48 hours in total
- •Patient in intensive care at Niort hospital
- •The trusted person or referent accepting the patient's participation
- •Patient affiliated to the social security system
排除标准
- •Known pregnancy
- •Patient who refused to participate in the study after the fact
- •Patients under long-term antidepressant treatment (treatment longer than 3 months)
- •Patients under guardianship or curatorship
- •Patient deprived of liberty
- •Skin lesions on the hands/feet/head (wounds, erythema, burns, bedsores, phlyctenes)
- •Inclusion in another clinical study
结局指标
主要结局
chemical restraint
时间窗: 1 year
Comparison of the proportion of patients who received chemical restraint during the sedation release phase until extubation between the two groups (experimental and control arms)
次要结局
- respiratory rate(T=0, T=30 nimutes, T=60 minutes, T= 90 minutes)
- cardiac frequency(T=0, T=30 nimutes, T=60 minutes, T= 90 minutes)
- self-extubations(1 year)
- patient discomfort(T=0, T=30 nimutes, T=60 minutes, T= 90 minutes)
- Ratio chemical restraint use(1 year)
研究者
研究点 (2)
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