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临床试验/NCT02502422
NCT02502422已完成不适用

Prediction of Optimal Laryngeal Mask Airway Cuff Volume From Parameters of Physical Examination of Head and Neck

Korea University Anam Hospital1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
optimal laryngeal mask airway cuff volume

研究概览

简要总结

Overinflation of laryngeal mask airway cuff increase side effect like hoarseness, vocal cord paralysis, sorethroat. The investigators will study correlation between laryngeal mask airway cuff volume and pressure and physical examination of head and neck.

详细描述

Overinflation of laryngeal mask airway cuff can induce side effects like hoarseness, vocal cord paralysis, sorethroat. Some study revealed that 60cmH2O of intracuff pressure is maximum pressure which is not increase side effect.

The manufacturer recommends that the cuff is inflated with the minimum volume of air required to provide an effective seal(max volume - size 3, 20 ml; size 4, 30 ml; size 5, 40).

The investigators will measure anatomical structure (neck circumference, neck length, thyroid-mental distance, etc.) which can influence cuff volume and pressure and find correlation between cuff volume and physical figure measured.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult (age 19-65)
  • •American Society of Anesthesiology Classification I-III

排除标准

  • •cardiovascular disease, cerebrovascular disease, pulmonary disease
  • •patient who have operation history for airway
  • •patient who expected difficult intubation
  • •patient who have risk of aspiration

研究组 & 干预措施

Classic laryngeal mask airway

Other

single arm

干预措施: Classic laryngeal mask airway (Device)

结局指标

主要结局

optimal laryngeal mask airway cuff volume

时间窗: 20minutes

◦The investigators remove air until gas leak occured around the cuff under airway pressure 15cm H20, fresh gas flow 6liters/min. Check the volume and pressure just before leakage occured.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hye-Won Shin

Director, MD, PhD

Korea University Anam Hospital

研究点 (1)

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