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临床试验/NCT02461017
NCT02461017已完成不适用

Endotracheal Tube Audible Leak Test: What is the Accuracy?

University of Mississippi Medical Center1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2015年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
Primary Objective Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak

研究概览

简要总结

The endotracheal tube (ETT) leak test (LT), or audible leak test is a widely performed assessment to verify appropriate tube size in neonates, infants and children. However, many factors are known to influence the audible leak test. Even though the test is widely performed, the accuracy has not been evaluated.

详细描述

The endotracheal tube (ETT) leak test (LT), or audible leak when the peak airway pressures reach 15-30 cmH2O, is a commonly performed assessment to confirm that an endotracheal tube size is appropriate for a child in order to minimize the risk of airway injury and adverse events after removal of ETT. Many factors are known to affect the results of the leak test and variation in results among experienced anesthesiologists may be as great as 38%, but the accuracy of the audible leak test by directly observing the presence of a leak around the ETT has not been evaluated. This study will attempt to use direct visualization of the air leak to correlate to and assess the accuracy of the audible air leak test.

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 Month 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged between 1 month (post-natal) and 8 years scheduled for ENT surgery requiring general anesthesia with an endotracheal tube.

排除标准

  • Known history of subglottic stenosis
  • Known history of recurrent croup
  • Known history of endolaryngeal or subglottic lesions
  • Parents refusal of participation in study

结局指标

主要结局

Primary Objective Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak

时间窗: one year.

Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak using a flexible nasal laryngoscope positioned superior to the laryngeal inlet.

次要结局

  • Secondary Objective Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's(one year.)

研究者

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

Madhankumar Sathyamoorthy

Assistant Professor

University of Mississippi Medical Center

研究点 (1)

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