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临床试验/NCT03023839
NCT03023839已完成不适用

Incidence and Risk Factors for Delirium in Severely Injured Patients

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
179
试验地点
1
主要终点
Incidence of delirium in trauma patients

研究概览

简要总结

Delirium is very common in intensive care unit (ICU) patients and leads to poor outcomes. There is little information on delirium in injured patients however. This study determined the incidence and risk factors for delirium in severely injured patients.

详细描述

This study was a prospective cohort study that reviewed the medical records of 179 trauma patients who were admitted to Asan Medical Center from January 01, 2013 to December 31, 2014. The investigators included all patients who had an Injury Severity Score (ISS) of more than 15 and excluded patients younger than 15 years old. This study was approved by the Asan Medical Center Institutional Review Board (2014-0344).

Patient delirium was checked using the Confusion Assessment Method in Intensive Care Unit (CAM-ICU) three times every day. The CAM-ICU includes four features that assess acute changes in or the fluctuating course of mental status, inattention, altered level of consciousness, and disorganized thinking. If a patient has a Richmond Agitation Sedation Scale (RASS) score of -3 or more with acute changes in mental status, inattention, and disorganized thinking or altered level of consciousness, a diagnosis of delirium can be made. The investigators considered patients to be delirious when CAM-ICU was positive for more than 24 h.

The investigators reviewed clinical information for the study patients including age, sex, and underlying disease. Trauma factors reviewed were cause of trauma, ISS, Glasgow Coma Scale (GCS) score, shock, initial lactate level, massive transfusion within 24 h, cardiopulmonary resuscitation rescue, and time taken to the hospital after trauma. Factors related to treatment included use of restraints, mechanical ventilation, and surgery. Clinical outcomes included mortality, ICU stay, mechanical ventilation duration, and hospital stay.

Statistical analysis were done using both univariate (chi-square test and t-test) and multivariate (logistic regression) procedures. Results are reported as mean ± standard deviation. Significance set at a P value of less than .05. For the multivariable logistic regression, the primary outcome variable of interest was the development of delirium after trauma that was classified as either present or absent. Variables were entered for analysis based on the strength of their univariate association with the presence/absence of delirium.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • trauma patients with Injury Severity Score (ISS) more than 15

排除标准

  • age under 15

结局指标

主要结局

Incidence of delirium in trauma patients

时间窗: within the 6 months after ICU admission

risk factors of delirium in trauma patients

时间窗: within the 6 months after ICU admission

次要结局

  • hospital stay of delirium in trauma patients(within the 6 months after ICU admission)
  • ICU stay of delirium in trauma patients(within the 6 months after ICU admission)
  • mechanical ventilation days of delirium in trauma patients(within the 6 months after ICU admission)
  • mortality of delirium in trauma patients(within the 6 months after ICU admission)

研究者

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

Suk-Kyung

associate professor

Asan Medical Center

研究点 (1)

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