跳至主要内容
临床试验/NCT06048198
NCT06048198已完成不适用

Incidence and Predictors of Delirium in the Trauma Intensive Care Unit:Prospective Study

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年8月23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
200
试验地点
1
主要终点
Predictors of delirium

研究概览

简要总结

Background Delirium is an acute neuropsychiatric syndrome, and its causes remain complex and not fully comprehended. Patients in trauma intensive care units are at high risk for delirium and are greatly affected by its adverse outcomes. As there are currently no effective pharmacological treatments or approaches for delirium, it is crucial to focus on identifying the risk factors for delirium and implementing early prevention strategies.

Objective Analyzing the incidence and risk factors of delirium in trauma intensive care unit patients.

Method This study is a prospective research that focuses on all patients in the trauma intensive care unit of a medical center. Data collection will be conducted through questionnaires and electronic medical records. A total of 200 participants will be conveniently selected for the study. Upon admission to the intensive care unit, each patient will complete a basic information questionnaire, and their medical records will be collected daily until they are discharged from the intensive care unit. The study incorporates various assessment scales including Intensive Care Delirium Screening Checklist (ICDSC), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Acute Physiology and Chronic Health Evaluation II (APACHE-II), Injury Severity Score (ISS), and Malnutrition Universal Screening Tool (MUST). Statistical analysis will be done by using IBM SPSS 24.0 for Windows. Descriptive statistics including mean, standard deviation, and percentages will be used to present demographic information. Logistic regression analysis will be applied to identify the key predictive factors for delirium risk.

Expected outcome and clinical application This study anticipates that the non-modifiable risk factors for trauma intensive care unit patients include age, substance use, chronic diseases, traumatic brain injury, prior surgery, frailty, APACHE II score, ISS, and ASA anesthesia classification. The modifiable risk factors include malnutrition, polypharmacy, electrolyte deficiency, metabolic acidosis, pain, mechanical ventilation, physical restraints, total surgical duration, intraoperative blood loss, and low hemoglobin. By understanding these risk factors, high-risk patients can be identified and preventive measures can be implemented to reduce the occurrence of delirium. Furthermore, addressing modifiable risk factors can help in reducing the risk or severity of delirium.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients who admitted to trauma intensive care unit.
  • Patients who belongs to surgical or trauma subject.

排除标准

  • Patients who stay in trauma ICU less than 24hrs.
  • Patients who can not communicate with Chinese or Taiwanese.
  • Patients who was diagnosed dementia.
  • Patients who was evaluated -4 or -5 on Richmond Agitation-Sedation Scale.

结局指标

主要结局

Predictors of delirium

时间窗: once per 2-days

The risk factors of delirium in the trauma ICU.(Age, APACHE II, ISS, MUST, 5-mFI, blood exam data...)

Delirium incidence

时间窗: once per day

The incidence of delirium in the trauma ICU.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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