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临床试验/NCT03929848
NCT03929848Unknown不适用

Minimum Cuff Pressure to Prevent Gas Leakage During Mechanical Ventilation in Laryngomicrosurgery - Pilot Study -

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年4月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
46
试验地点
1
主要终点
Cuff pressure

研究概览

简要总结

The goal of this prospective observational study is to investigate minimum cuff pressure to prevent gas leakage during mechanical ventilation in laryngomicrosurgery.

详细描述

It has been well known that cuff pressure should be adequately limited to prevent ischemic injury of tracheal mucosa, which is about 20-30 mmHg. However, higher cuff pressure that 20-30 mmHg might be required to prevent gas leakage during general anesthesia for laryngomicrosurgery.

The hypothesis of this study is that the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery, and there will be no damage from the required cuff pressure because of short time of surgery.

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

入选标准

  • patients who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule

排除标准

  • Who doesn't agree to enroll
  • do not use a reinforced tracheal tube of internal diameter of 5.5 mm for male patient
  • do not use a reinforced tracheal tube of internal diameter of 5.0 mm for female patient

结局指标

主要结局

Cuff pressure

时间窗: intraoperative

the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery

post operative complication

时间窗: from end of surgery to 1-2 weeks after surgery

any postoperative symptoms associated with cuff pressure such as hoarsness, dyspnea

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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