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临床试验/NCT03194360
NCT03194360已完成不适用

Risk Factors of Delirium in Sequential Sedation Patients in Intensive Care Unit

West China Hospital1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
141
试验地点
1
主要终点
Delirium assessment in Sequential Sedation Patients

研究概览

简要总结

Delirium is one of main adverse events in ventilated patients who receive long-term usage of mono-sedative. Sequential sedation may reduce these adverse effects. This study aimed to evaluate incidence and risk factors for delirium in sequential sedation patients.

详细描述

Previous studies have showed that patients under mechanical ventilation have a higher risk for experiencing delirium than nonmechanically ventilated patients (20%-50%). Its occurrence is also more frequent in elder patients. More than that, it is often hard to identify delirium by physicians, leading to unreasonable management of ICU patients.

And delirium is one of main adverse events in ventilated patients who receive long-term usage of mono-sedative. Sequential sedation may reduce these adverse effects.

However, few present studies focus on delirium in sequential sedation patients. Thus, in this study, we aimed to determine the factors of delirium in patients who received sequential sedation in ICU.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intubated patients;
  • Age≥18 years old;
  • Anticipated Ventilation and sedation duration of at least 72 hours.

排除标准

  • Allergy to the study drug;
  • suspected pregnancy;
  • gross obesity;
  • Extremely unstable of circulatory system, such as systolic blood pressure less than 90 mm Hg despite plasma volume expansion and continuous infusions of vasopressors before the start of study drug infusion;
  • Uncontrolled abnormal hypertension, such as systolic blood pressure more than 180 mmHg or diastolic more than105 mmHg;
  • Heart rate less than 50 bpm;
  • Second or third degree heart block;
  • moribund state;
  • history of alcoholism or intake of anti-anxiety drugs or hypnotics;
  • chronic renal failure;
  • coma by cranial trauma or neurosurgery or unknown etiology or epileptic state;
  • History of neuromuscular disease;
  • unwillingness to provide informed consent by patients or their authorized surrogates following ICU admission.

结局指标

主要结局

Delirium assessment in Sequential Sedation Patients

时间窗: A maximum of twenty-eight days or until ICU discharge, whichever occurred first.

The primary outcome of this study was delirium. Patient evaluations were implemented using Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale every four hours a day for a maximum of twenty-eight days or until ICU discharge, whichever occurred first. The risk factors were analyzed using risk regression (logistic-regression). Any variables which had P\<0.2 after univariable logistic-regression or potential variables associated with delirium were included for multivariable logistic-regression. P\<0.05 was considered to represent statistical significance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kang Yan

Study Chair: Y Kang, Dr Critical Medicine Department,West China Hospital of Sichuan University

West China Hospital

研究点 (1)

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