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
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
- 否
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
研究点 (2)
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