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临床试验/NCT02882594
NCT02882594已完成不适用

Testing the Reliability and Validity of the CIBA

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2016年3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
384
试验地点
1
主要终点
Test the reliability and validity of the Child Induction Behavioral Assessment (CIBA) Tool by evaluating inter-rater reliability and concurrent reliability and validity of the CIBA tool with the already validated Induction Compliance Checklist (ICC)

研究概览

简要总结

The overall objective of the study is to improve the experience for pediatric patients undergoing anesthesia inductions. The specific objective for this proposal is to establish whether the CIBA tool demonstrates inter-rater reliability and concurrent validity with the Induction Compliance Checklist.

详细描述

The proposed research study will assess the reliability and validity of a new tool that is being used in the Department of Anesthesia (The Child Induction Behavioral Assessment tool) to grade the difficulty of patient behaviors exhibited during anesthesia inductions. The Child Induction Behavioral Assessment (CIBA) tool is more succinct than previously validated tools for assessing behavioral responses to inhalation inductions, making it practical for use in a busy clinical practice setting. Having clinicians document a patient's behavioral response to induction using the CIBA tool is useful because this information can help to optimize subsequent induction plans if the patient returns. Additionally, population data may be collected using electronic data reports for QI purposes. Prior to using data from the CIBA tool in QI initiatives, it is important to assess whether this tool is reliable and valid.

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
1 Year 至 13 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Presenting to Same Day Surgery department at CCHMC base campus for any surgical or Intervention Radiology procedure
  • •Ages 1-13 years old
  • •Male or female
  • •Patients of any ethnicity
  • •Family and participant communicate primarily in English
  • •Patients with normal neurocognitive development
  • •Patients undergoing inhalation induction using an anesthesia mask
  • •American Society of Anesthesiologists (ASA) physical classification status I, II, or III
  • •Patients who do or do not receive a premedication for anxiety
  • •Parent/guardian present at the induction of anesthesia

排除标准

  • •Guardian unavailable to give consent
  • •Neurocognitive delays
  • •Tracheostomy
  • •Intravenous (IV) induction or nitrous sedation prior to IV induction
  • •Coordinators unable to observe or fully observe the induction
  • •CIBA assessment not completed by anesthesia provider

结局指标

主要结局

Test the reliability and validity of the Child Induction Behavioral Assessment (CIBA) Tool by evaluating inter-rater reliability and concurrent reliability and validity of the CIBA tool with the already validated Induction Compliance Checklist (ICC)

时间窗: two years

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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