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临床试验/NCT03938506
NCT03938506Unknown不适用

The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes

Yonsei University1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2019年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
208
试验地点
1
主要终点
The incidence rate when the pressure in the cuff of the endotracheal tube is not within the proper range.

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 common method to inflate the endotracheal tube cuff is palpation method. However, the palpation of the cuff is not accurate because of the different size between the pilot balloon and the cuff. Thus, the investigators hypothesized that the different size of the tube will affect the accuracy of the palpation method.

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

  • Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0

排除标准

  • Patients under 20 years old
  • Patients receiving emergency surgery
  • Patients with tracheostomy tubes
  • Pregnant women
  • Patients who can not read the consent form or are not fluent in Korean
  • Patients who refused the clinical trial
  • Patient with endotracheal mass in the trachea where the cuff is located
  • Tracheal deviation is observed in the neck due to tumor in the neck

结局指标

主要结局

The incidence rate when the pressure in the cuff of the endotracheal tube is not within the proper range.

时间窗: participants will followed until the completion of the anesthetic induction (less than 15 minutes).

the investigator will monitor the pressure of the endotracheal tube cuff after anesthetic induction.

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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