跳至主要内容
临床试验/NCT03224611
NCT03224611已完成不适用

Usefulness of Light Wand-guided Insertion of Flexible Reinforced Laryngeal Mask Airway: Comparison With Conventional Blind-insertion

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017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
发起方
入组人数
54
试验地点
1
主要终点
Oropharyngeal leak pressure

研究概览

简要总结

Flexible LMA (Laryngeal mask airway) is very useful for variable situation but it is hard to insert in correct position because of it's flexible structure. Especially in classical way of manual LMA insertion, when the index finger could not guide the flexible LMA to the optimal position, we could not guarantee the correct position of the LMA. Therefore several studies have been investigated to improve this.

The light wand is a kind of stylet which have a light on the tip. Recently some studies demonstrated the usefulness of the light wand which could be used for indicating correct position of the LMA. We hypothesised there will be two advantages if the light wand is used as a stylet of the flexible LMA. First the stylet could support the mildness of the flexible LMA, and second the lightness could confirm the correct position of the flexible LMA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient need general anesthesia using LMA and belonged to the ASA(American society of Anesthesiologist) class I or II

排除标准

  • The patient who has URI(upper respiratory infection) symptom within 14 days or
  • The patient's BMI(body mass index) exceeds 35 kg/m2
  • The patient has severe GERD(gastroesophageal reflux disease) or hiatus hernia
  • The patient who has any contraindication for LMA insertion

研究组 & 干预措施

Control group

No Intervention

The flexible LMA is inserted using "index finger technique"

Light wand group

Active Comparator

The flexible LMA is inserted using light wand as a stylet

干预措施: light wand (Device)

结局指标

主要结局

Oropharyngeal leak pressure

时间窗: 5 minutes after LMA is inserted

The oropharyngeal leak pressure is measured by the pressure which the investigator could detect the audible sound by stethoscope on patient's cheek during the exhaust valve is closed and the fresh gas is allowed to flow into the lungs at 3 liters per minute.

次要结局

  • The grade of oropharyngeal view through the fiberoptic assessment(5 minutes after LMA is inserted)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiyoung Yoo

clinical assistant professor

Ajou University School of Medicine

研究点 (1)

Loading locations...

相似试验