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临床试验/NCT03087838
NCT03087838已完成不适用

Postoperative Delirium in Adult Patients After Elective Craniotomy Under General Anaesthesia: a Prospective Cohort Study

Capital Medical University1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
800
试验地点
1
主要终点
Postoperative delirium

研究概览

简要总结

Postoperative delirium may result in many adverse complications. At present little is known about postoperative delirium in patients after crniotomy because they may manifest similar symptoms to definitely delirium for some structural brain disease. Objective of this study is to find out incidence and risk factors of postoperative delirium in patients after elective craniotomy and also the relationship of postoperative delirium with clinical outcome.

详细描述

The study is a prospective single-center cohort study. Consecutive adult patients admitted to the ICU after elective craniotomy is enrolled. Richmond Agitation Sedation Scale (RASS) is used to assess level of consciousness of patients; if conditions met "RASS≥-3", the Confusion Assessment Method for the Intensive Care Unit will proceed to evaluate delirium signs in patients. Delirium is assessed every 12-hour shift within 3 days during the patient's ICU stay and ended when discharged from ICU or dead, time started at 9am and 9pm. On the third day after operation when most patients have been transferred to general ward, delirium was assessed only at 9am for follow-up studies. Patients is divided into two groups via assessment of CAM-ICU: delirium groups and non-delirium groups. Factors potentially related to postoperative delirium are collected and categorized as preoperative, intraoperative and postoperative in chronological order. Univariate analyses between delirium groups and non-delirium groups is performed. The stepwise backward logistic regression is carried out to identify the independent predictors of delirium. Patients will be followed up until hospital discharge, death or 90 days after the enrollment. Clinical outcome such as days on the mechanical ventilator, endotracheal extubation time, need for re-intubation and tracheotomy, unexpected reoperation within 72 h after surgery, length of stay in the ICU , hospital costs and mortality will be registered.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients after elective craniotomy under general anaesthesia and admitted to the ICU directly after surgery.

排除标准

  • Patients younger than 18 years
  • Patients with emergency operation
  • Patients with preoperative impairment of consciousness (GCS<8)
  • Patients with a past medical history of delirium or schizophrenia(evaluated by the medical document)
  • Patients withventriculoperitoneal shunt or endoscope operation
  • Patients with inability to communicate in the preoperative period(including language barrier)
  • Pregnant or lactating women.

结局指标

主要结局

Postoperative delirium

时间窗: Within the first 24 hours after operation

CAM-ICU is positive

次要结局

未报告次要终点

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian-Xin Zhou

professor

Capital Medical University

研究点 (1)

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