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临床试验/NCT03938493
NCT03938493已完成不适用

Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia

Yonsei University1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2020年4月28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
201
试验地点
1
主要终点
Changes of cuff pressure during anesthesia

研究概览

简要总结

Endotracheal tube is a commonly used for general anesthesia in head and neck surgery. It is necessary to place the endotracheal tube in the trachea of the patient and then inflate the cuff with air. This is because the air-inflated cuff contacts the inner wall of the patient's trachea to deliver oxygen through the tube. If the cuff does not inflate, oxygen will leak through the space between the cuff and the patient's trachea. In addition, the risk of pneumonia increases. Therefore, after placing the endotracheal tube in the patient's trachea, the cuff is immediately inflated with air. However, when the cuff is inflated using an excess of air, the cuff may pressurize the mucous membrane of the tracheal wall and cause ischemia. Pressure in the over-inflated cuff was also found to be associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Therefore, appropriate amount of air should be used to inflate the cuff into the air and adjust the pressure within the cuff to be within the range of 20-30 cmH2O. The authors thought that the pressure in the cuff could be changed during the operation due to various factors and that the pressure in the cuff should be monitored continuously. In this study, the investigators will monitor the cuff pressure during anesthesia and analyze the factors affecting the cuff pressure.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults who require endotracheal intubation for head and neck surgery under general anesthesia

排除标准

  • Patients under 20 years old
  • Patients who should undergo tracheostomy
  • Patients who need to use an endotracheal tube without a cuff
  • Pregnant women
  • Patients who can not read the consent form or are not fluent in Korean
  • Patients who refused the clinical trial

结局指标

主要结局

Changes of cuff pressure during anesthesia

时间窗: participants will followed until post-operative 1 day.

The investigators will monitor the pressure of the endotracheal tube cuff during anesthesia. The changes of the cuff pressure from the baseline value will be monitored continuously.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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