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临床试验/NCT04441970
NCT04441970Unknown不适用

The Influence of Head and Neck Position on the Cuff Pressure Using Nasotracheal Tube

Yonsei University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
cuff pressure of the nasotracheal tube

研究概览

简要总结

Nasotracheal tube is a commonly used for securing airways when performing general anesthesia in various oral and maxillofacial surgery such as tooth extraction, maxillary and mandibular fractures. After the nasotracheal tube is placed in the patient's trachea, the process of inflating the cuff at the end of the tube with air is required. If the cuff is inflated with excess air, the cuff may press the mucous membrane on the inner wall of the trachea, causing ischemia. Previous studies have shown that if the pressure in the cuff exceeds 30 cmH2O, it is highly likely to cause ischemia. In addition, it was found that the pressure in the excessively inflated cuff was associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Moreover, the pressure in the cuff may vary according to the patient's head and neck posture. The pressure changes in the cuff may vary depending on the material and shape of the cuff. Therefore, we will investigate to evaluate the effect of head and neck posture on the pressure in the cuff of nasotracheal tube.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Adult patients over 20 years of age
  • patients who require intubation of the nasotracheal tube to undergo oral and maxillofacial surgery under general anesthesia

排除标准

  • Patients whose neck cannot be rotated due to cervical diseases, cervical fractures, and previous cervical surgery
  • Patients undergoing emergency surgery
  • Pregnant women

结局指标

主要结局

cuff pressure of the nasotracheal tube

时间窗: for 10 minutes after intubating the nasotracheal tube. At Day 0.

Cuff pressure will be measured in the various head and neck positions.

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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