Subsyndromal Delirium in Intensive Care Unit, a Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Subsyndromal delirium (SSD) is a condition characterized by a less severe cognitive impairment in comparison to delirium. To date there is no published consensus on SSD definitions and has been commonly reported as an intermediate stage between delirium and normal mental states.
SSD encompasses some of the delirium symptoms, and has been diagnosed with Intensive Care Delirium Screening Checklist scale (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU).
The objective of this study is to identify subsyndromal delirium prevalence, the association between SSD and clinical outcomes and understanding the relationship between SSD and conversion to delirium.
The relevance of this study is understanding of subsyndromal delirium in ICU, namely the importance of early presentations of acute brain dysfunction in the patients outcome.
详细描述
SubSynD is a prospective, observational, multicenter clinical study, involving 400 patients in Intensive Care Units, to assess subsyndromal delirium.
A systematic screening for delirium and subsyndromal delirium (SSD) is done with Intensive Care Delirium Screening Checklist (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU). Scales are applied once per day until ICU discharge or for up to 14 days of being in ICU.
The investigators access three different groups of patients: non-delirium, delirium and subsyndromal delirium. It is intended that either ICDSC or CAM-ICU, paired with a Richmond Agitation and Sedation Scale (RASS) be administered once per day (i.e. with first assessment in the morning). All patients with abnormal CAM-ICU or ICDSC features, beside the underlying cause of delirium and SSD are included. In addition, data regarding baseline demographic and clinical characteristics will be collected as well as data regarding the procedure performed (see Case Report Form (CRF)).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Admission in Intensive care Unit
排除标准
- •Primary neurological diagnosis, with Glasgow Coma Scale (GCS) <14 on ICU admission or in previous days;
- •Blindness or deafness;
- •Inability to communicate in the native language of the country where the study is enrolled;
- •Death during the first 24 hours;
- •Limitation of therapeutic efforts in the Intensive Care Unit admission;
- •Refusal to participate;
- •Previous diagnosis of dementia or psychiatric illness;
- •Readmission in ICU;
结局指标
主要结局
Mortality
时间窗: 28 days
defined as number of days that patients survived in 28 days
Ventilation free days
时间窗: 28 days
defined has the number of days from day 1 to day 28 on which a patient breathed without assistance
Number of patients with conversion from subsyndromal delirium to delirium during the period of study
时间窗: 14 days
ICDSC performed 1 time per day and determine how subsyndromal delirium (ICDSC 1-3) can have conversion to delirium (ICDSC \>/=4).
次要结局
- ICU length of stay(24 months)
- Hospital length of stay(24 months)
研究者
Maria Carolina Vieira Júlio Paulino
Principal Investigator
Centro Hospitalar Lisboa Ocidental