跳至主要内容
临床试验/NCT01957566
NCT01957566已完成不适用

The Utility of Amplified Pretracheal Stethoscope in Detecting Ventilatory Abnormalities During Propofol Sedation of Non Intubated Children: a Validation Study

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2015年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
An auscultation of a stridor score greater than or equal to 2 will be defined as a sedation-related adverse acute respiratory event

研究概览

简要总结

The purpose of the study is to validate the diagnostic performance of the amplified pretracheal stethoscope (APS) to detect sedation-related adverse acute respiratory events in propofol sedated nonintubated children. To determine the sensitivity/specificity and positive/negative predictive value of the APS in detecting sedation-related adverse acute respiratory events in propofol sedated nonintubated children.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • Patients 2 years to 18 years of age undergoing induction and maintenance of propofol sedation at the American Family Children's Hospital (AFCH) Pediatric Sedation Clinic
  • American Society of Anesthesiology score (ASA) of 1-2

排除标准

  • ASA scoring > 3
  • Oxygen requirement and cardiorespiratory instability
  • Allergy to propofol or its components
  • Patients requiring propofol sedation outside the AFCH Pediatric Sedation Clinic

研究组 & 干预措施

APS

Experimental

干预措施: APS (Procedure)

结局指标

主要结局

An auscultation of a stridor score greater than or equal to 2 will be defined as a sedation-related adverse acute respiratory event

时间窗: Day 1 of propofol sedation.

A stridor score of less than 2 will be defined as not sedation-related event.

时间窗: Day 1 of sedation.

次要结局

  • The positive predictive value and negative predictive value of the APS for predicting airway obstruction.(Day 1 of propofol sedation.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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