Prevention of Delirium After Acute Surgery - Implementation of a Multicomponent Intervention Throughout the Hospitalization
试验速览
- 阶段
- 不适用
- 入组人数
- 476
- 试验地点
- 1
- 主要终点
- Postoperative delirium identified with the screening tool Confusion Assessment Method (CAM), assessing change from negative to positive score.
研究概览
简要总结
The aim of this trial is to evaluate the implementation and effect of an evidence based, multicomponent intervention on postoperative delirium, when fast implemented throughout the patients stay in hospital before, during and after acute surgery in a risk population, the primary outcome being frequency of patients with positive Confusion Assessment Method (CAM) score.
The hypothesis is that the frequency of postoperative delirium will be reduced after implementation of the preventive interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician will be blinded from the groups, when assessing the primary outcome.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40 or above.
- •Patients scheduled for acute abdominal or orthopaedic surgery in general anaesthesia with an expected duration of 30 minutes or more.
- •Patients who are scheduled for surgery within 72 hours of hospital admission.
- •Patients who are expected to stay in hospital for 24 hours or more.
排除标准
- •Patients screened CAM positive before surgery.
- •Patients who have already been included in the study
- •Patients unable to speak and read Danish.
- •Inability to provide consent.
结局指标
主要结局
Postoperative delirium identified with the screening tool Confusion Assessment Method (CAM), assessing change from negative to positive score.
时间窗: During the 5 initial postoperative in-hospital days. Patients are screened twice a day; in the morning (7-10 AM) and in the evening (7-11 PM).
Patients are screened with the tool Confusion Assessment Method (CAM). A patient will be considered CAM positive, according to the CAM algorithm for diagnosis of delirium that requires the presence of both the first (acute onset and fluctuating course) and the second criteria (inattention) and of either the third (disorganised thinking) or the fourth criterion (altered level of consciousness).
次要结局
- Length of stay in the Post-Anaesthesia Care Unit (PACU) after surgery.(Day 30)
- All-cause mortality within 30 days.(Day 30)
- Number of participants who are admitted to the intensive care unit after the operation.(Day 30)
- Number of patients in need of re-operation(Day 30)
- Length of postoperative stay (LOS).(Day 30)
- Number of participants who are readmitted to hospital within 30 days.(Day 30)
- Inadequate emergence identified with the screening tool Confusion Assessment Method (CAM) in the Post-Anaesthesia Care Unit (PACU), assessing change from negative to positive score.(Patients are screened at time of arrival and until discharge from PACU)
研究者
Sine Eriksen
Principal Investigator
Bispebjerg Hospital