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临床试验/NCT01669993
NCT01669993已完成不适用

Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2012年5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
2,400
试验地点
1
主要终点
Emergency Room Admissions

研究概览

简要总结

The purposes of the study are to identify 1) the patient (demographic and clinical) and health care system factors predictive of immediate and late postoperative adverse outcomes in children undergoing tonsillectomy. 2) Evaluate the preoperative use of the sleep questionnaire to identify children at risk for immediate and late postoperative adverse outcomes in children undergoing tonsillectomy.

详细描述

Currently, children are scheduled to go home or stay in the hospital depending on expert consensus and institutional guidelines. The investigators preliminary experience (Dr. Sadhasivam PI: IRB No. 2008-0848) with the pharmocogenetic study, studying the phenotypic and genotypic influences of pain and use of opioids in patients undergoing tonsillectomy indicates that a significant number of patients scheduled as outpatients experience prolonged recovery phases in the PACU, some of whom are admitted or re-admitted following discharge. The identification of those factors that are, predictive of adverse events in tonsillectomy patients and the development of a prototype prediction model in this single-center study to support clinical decision-making. The rationale of this project is that developing a model to predict postoperative adverse events will not only lead to improved clinical outcomes and enhance patient safety, but also reduce family psychosocial distress associated with unanticipated hospital visits or re-admission, while reducing the burden on the health care system.

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
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 0-17 years of age
  • Children scheduled for tonsillectomy or adeno-tonsillectomy
  • ASA I, II, or III

排除标准

  • ASA IV and V

结局指标

主要结局

Emergency Room Admissions

时间窗: Upto 3 weeks after surgery

次要结局

  • Postoperative Adverse Event(Assessed in post anesthesia care unit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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