The Impact of Audio and Visual Intervention in Preventing ICU Delirium in Critically Ill Patients : A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Number of patients with delirium
研究概览
简要总结
This study was designed to evaluate the impact of non-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit.
详细描述
Delirium significantly increases not only the length of the intensive care unit stay and overall mortality, but also the likelihood of persistant cognitive impairment after recovery. However there is no definitive treatment for delirium, thereby it is important to prevent delirium before it occur. Researches also have focused on the prevention of delirium or the reduction of duration of delirium.
Several studies evaluated the effect of non-pharmacological treatment, such as improvement of orientation, prevention of sensory deprivation, active pain control and prevention of dehydration, to reduce the occurrence of delirium and the results were inconsistent depending on the patients included. However, there have been no randomized clinical trials that have tested the effect of prevention of delirium by applying non-pharmacological multimodal approaches in the intensive care unit for Korean patients.
A randomized controlled trial was planned to evaluate the impact of on-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit in Korea.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over 50 years who are expected to spend more than 24 hours in the intensive care unit
排除标准
- •Patients who developed delirium before entering the intensive care unit
- •Patients with cognitive impairment
- •Patients who have hearing or vision deficits, or have difficulty in communication
- •Patients who are expected to die within 24 hours or do not want life-sustaining treatment
研究组 & 干预措施
Multimodal therapy group
Continuous regional cerebral oxygen saturation and processed electroencephalogram (EEG) are monitored.
Multimodal therapy with conventional care are provided to prevent delirium. Ongoing orientation: 3 times per day Sensory correction: the hearing device and the glasses are supplied. Cognitive stimulation: a portable monitor is used to provide visual stimulation, and a directional speaker is used to avoid disturbing the alarm of the patient's life supportimng system.
Sleep promotion: the lights are turned off from 10 pm to 7 am, and the indirect light source is used if necessary.
干预措施: Multimodal therapy for prevention of delirium (Other)
Conventional care group
Continuous regional cerebral oxygen saturation and processed electroencephalogram (EEG) are monitored.
Conventional care: If sedation is required, dexmedetomidine is considered as the first-line sedative drug. The sedation is interrupted daily and the possibility of awakening is assessed. Pain with NRS score above 3, is controlled with opioid.
For patients with Richmond Agitation Sedation Scale (RASS) -4 or -5, possible items are provided.
结局指标
主要结局
Number of patients with delirium
时间窗: From ICU admission up to day 28 or discharge from ICU or death
Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)
次要结局
- Accidental extubation or disconnection of treatment devices(From ICU admission up to day 28 or discharge from ICU or death)
- Delirium-free days(From ICU admission up to day 28 or discharge from ICU or death)
- ICU and hospital length of stay(From ICU admission up to day 28 or discharge from ICU or death)
- Severity of delirium(From ICU admission up to day 28 or discharge from ICU or death)
研究者
Ho Geol Ryu
Professor
Seoul National University Hospital