DANish DELIrium Study On Neurointensive Care Patients. A Two Phase Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Duration of delirium symptoms.
研究概览
简要总结
Abstract Background Studies have shown that delirium in medical and surgical intensive care units (ICUs) increases mortality, length of stay (LOS) as well as the risk of dementia symptoms and cerebral atrophy after discharge. Only few studies have investigated delirium in the neurointensive care unit (N-ICU). Delirium is most often assessed by one of two instruments: Intensive Care Delirium Screening Checklist (ICDSC) or the Confusion Assessment Method for the ICU (CAM-ICU).
Aims
- To measure the effect of a systematic intervention (sedation, sleep, mobilization and pain) on delirium symptoms in patients with acute acquired brain injury in N-ICU.
- To validate the ICDSC and CAM-ICU to patients with acute acquired brain injury Method The design of the study is a two-phase interventional trial. Based on a power calculation, 56 patients will be enrolled both in the baseline and the intervention group (n=112).
Part 1: A baseline investigation will be conducted to establish prevalence, duration and type of delirium symptoms in patients with acute acquired brain injury before implementing the intervention bundle.
Part 2: A systematic Intervention protocol will be implemented in the N-ICU. The Intervention elements consist of a sedation, sleep, mobilization and pain treatment regimen based on the newest available evidence.
Enrolled patients will be contacted 12 months after discharge for a follow-up including a quality of life with (EuroQoL-5D) questionnaire, a cognitive test measuring their cognitive end point (Repeatable Battery for Assessment of the Neuropsychological Status) and a short test for dementia symptoms (MMSE, Mini Mental State Examination).
详细描述
Background It has been established that in medical and surgical intensive care units (ICUs) that delirium increases mortality and length of stay (LOS), as well as the risk of dementia and cerebral atrophy after discharge. There is a lack of studies into delirium in the neurointensive care unit (N-ICU) population, and no studies have addressed the association between delirium, quality of life, dementia symptoms and cerebral atrophy in patients with acquired brain injury after discharge from N-ICU. A recent study has demonstrated a correlation between delirium symptoms in stroke patients and quality of life, and functional levels at 3, 6 and 12 months after N-ICU discharge, suggesting that delirium during the acute phase effects the long-term outcome.
Delirium screening has not been introduced systematically in N-ICUs in Denmark or internationally, and validated instruments are lacking in this population. The Confusion Assessment Method for ICU (CAM-ICU) and the Intensive Care Delirium Screening Checklist (ICDSC) are internationally most recommended and best validated delirium screening tools for non-psychiatric health care staff. Neither of the two instruments, however, has been fully validated in patients with acquired brain injury.
Several studies and guidelines suggest that delirium is potentially preventable by minimizing sedation, and ensuring systematic pain management, early mobilization and adequate sleep. The present study therefore aims to investigate if delirium is preventable in an N-ICU setting by introducing a multi-modal intervention bundle optimizing management of sedation, pain, mobilization and sleep.
Aim
The primary aim of the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Danish speaking adults (18 years or above)
- •Expected N-ICU length of stay (LOS) more than 48 hours
- •Admitted with acute brain injury from subarachnoid hemorrhage (SAH), intracranial hemorrhage (ICH) or traumatic brain injury (TBI).
排除标准
- •Patients not expected to survive 48 hours
- •Richmond Agitation-Sedation Score (RASS) of -4 or -5 during the stay in the N-ICU.
结局指标
主要结局
Duration of delirium symptoms.
时间窗: Minimum 48 hours and up to 4 weeks
Patients are assessed two times per day for delirium symptoms with ICDSC and the CAM-ICU during their stay on the N-ICU. duration of delirium symptoms measured by CAM-ICU and ICDSC will be analysed individually and the one with the best performance test will be presented as the primary outcome measure.
次要结局
- Validation of ICDSC and CAM-ICU(2 days. On the first and second assessable day (RASS -2 or above).)
- Prevalence of delirium symptoms(1 day and up to 4 weeks.)
- Mortality(1 year)
- cognitive function after 12 month after discharge(12 month)
- Length of Stay(2 days (48 hours) and up til 4 weeks)
- Quality of life after 12 month after discharge(12 month)
- Type of delirium symptoms(1 day (24 hours) and up to 4 weeks.)
研究者
Kirsten Moller
Professor, dept. of Neuroanaesthesiology
Rigshospitalet, Denmark