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临床试验/NCT00968058
NCT00968058已完成不适用

Temporal Variation of the Leak Pressure of Uncuffed Pediatric Endotracheal Tubes Following Intubation: A Prospective Observational Study

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年6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
40
试验地点
1
主要终点
Changes in leak pressure following endotracheal tube placement

研究概览

简要总结

Children and adults frequently need a 'breathing tube' when having anesthesia for surgery. The breathing tube is usually inserted after the anesthesia doctor puts a patient to sleep with medicine, so they do not feel the breathing tube. In children, there is often a leak of air between the tube and the windpipe, as the tube is not an exact fit. Anesthesia doctors usually listen for this leak around the tube by listening to the chest with a stethoscope while gently filling the lungs with oxygen from the anesthesia machine. The leak tells them if the tube is the correct size, or too small, or too tight. If it is too small, or too tight, they usually change the tube for a better fit.

The purpose of this study is to see what happens to this leak in the 30 minutes after the tube is placed. No one really knows if the leak gets bigger, smaller, or stays the same. Knowing what happens to the leak will help anesthesia doctors to decide whether to change the breathing tube or not. This is important, as a tube that is too tight can lead to breathing difficulty after removing the tube at the end of surgery, and a tube that is too small may make it difficult for the breathing machine to work effectively for the patient as a result of a large leak of air or oxygen.

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 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 0-7 years of age
  • Surgery with planned endotracheal intubation using an uncuffed ETT.
  • Supine position

排除标准

  • Lack of parental consent
  • Rapid sequence induction with cricoid pressure
  • Use of neuromuscular blocking agent/s for intubation.
  • Active gastroesophageal reflux disease
  • Active upper respiratory tract infection
  • Chronic active lung disease requiring frequent treatment such as asthma, or chronic lung disease of prematurity etc.
  • Surgery in the lateral or prone position
  • Oropharyngeal, neck , laryngeal, or laparoscopic surgery
  • Tracheostomy in-situ
  • History of previous laryngeal or tracheal surgery
  • History of tracheal or laryngeal abnormalities, or stridor of unknown origin.
  • History of symptomatic neuromuscular disease or paralysis
  • History or features suggestive of a difficult airway on pre-anesthetic evaluation and physical examination.

结局指标

主要结局

Changes in leak pressure following endotracheal tube placement

时间窗: Thirty minutes after tube placement

次要结局

未报告次要终点

研究者

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

Kirk Lalwani

Associate professor Anesthesiology and Pediatrics

Oregon Health and Science University

研究点 (1)

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