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临床试验/NCT02376179
NCT02376179已完成不适用

Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Tonsillectomy and/or Adenoidectomy

Kris Jatana1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
Changes in the Intracuff Pressure

研究概览

简要总结

We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.

排除标准

  • Patient who is intubated with an uncuffed endotracheal tube.
  • Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.

结局指标

主要结局

Changes in the Intracuff Pressure

时间窗: during time of surgery

Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.

次要结局

未报告次要终点

研究者

发起方
Kris Jatana
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kris Jatana

ENT Surgeon

Nationwide Children's Hospital

研究点 (1)

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