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临床试验/NCT02058030
NCT02058030已完成不适用

The 3 cm of Head Elevation Provides Higher Insertion Success Than do the 6 cm of it for ProSeal Laryngeal Mask Airway Insertion in Adult Patients

National Medical Center, Seoul2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
insertion success rate

研究概览

简要总结

Background - The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway insertion

Methods

  • This prospective randomized, controlled study included 80 adult patients . In the 3 cm (n=40) or 6 cm group (n=40), the PLMA was inserted while the head is placed on the 3 cm or 6 cm height of pillow. The success rate at first and second attempt, insertion time, blood staining on cuff, sore throat and hoarseness were assessed.

详细描述

Background: The "sniffing position" (i.e., the neck flexed and head extended by means of a pillow) eases tracheal intubation because the three axes, namely, the axis of the mouth, the pharyngeal axis and the laryngeal axis, are put in almost a straight line. The benefit of the sniffing position that align three axis could possibly be applicable when the ProSeal LMA is inserted. For the endotracheal intubation, it has been recommended to elevate the patient's head 8 to 10 cm with pads under the occiput (shoulder remaining on the table) and extend the head at the atlanto-occipital joint to align the oral, pharyngeal, and laryngeal axes such that the passage and line of vision from the lips to the glottic opening are most nearly a straight line.

There have been several clinical studies about the effect of head and neck position including neutral, flexion or extension on the ease of LMA insertion.

However, it has not been much recommended or investigated about the influence of head elevation on the insertion success of PLMA until now. The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSeal laryngeal mask airway insertion in adult patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status 1-2
  • scheduled for minor surgery in the supine position were enrolled

排除标准

  • cardiorespiratory disease patients
  • patients were at risk of aspiration

结局指标

主要结局

insertion success rate

时间窗: 2013.11 - 2014.12

次要结局

  • complication(2013.11- 2014.12)

研究者

发起方
National Medical Center, Seoul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sung Hoon Kim

MD

National Medical Center, Seoul

研究点 (2)

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