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临床试验/NCT02252120
NCT02252120已完成不适用

Laryngeal Mask Airway Supreme Versus Laryngeal Tube in Non-paralysed, Anesthetized Children. A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position Using the Size 2

Schulthess Klinik0 个研究点目标入组 60 人开始时间: 2014年1月最近更新:
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
60
主要终点
Oropharyngeal leak pressure

研究概览

简要总结

The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in non-paralyzed anaesthetized pediatric patients

详细描述

The Laryngeal Tube LTS IITM (VBM-Medizintechnik GmbH, Sulz a.N, Germany) is a well established reusable latex free, extraglottic airway device. A proximal (pharyngeal) and a distal (esophageal) cuff are inflated with a single cuff pilot line. In between lies the ventilation orifice. The LMA SupremeTM (Teleflex San Diego, CA, USA) is a single use well studied laryngeal mask airway. Both devices have a drain tube to allow access to the gastrointestinal tract. Actually there are no studies comparing Laryngeal Tube LTS IITM and LMA SupremeTM use in small children. Therefore the aim of this study was to evaluate the clinical performance of the Laryngeal Tube LTS IITM compared to the LMA SupremeTM. The investigators hypothesized that design differences should lead to differences in efficacy of seal and anatomic position. In this randomized, crossover study, the investigators test the hypothesis that in non-paralyzed pediatric patients the oropharyngeal leak pressure and fiberoptic position differs between the size 2 Laryngeal Tube LTS IITM and the LMA SupremeTM.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Months 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age 1.5 - 9 years
  • minor surgery
  • extraglottic airway device

排除标准

  • age (<18 months, >9 years)
  • weight (<10 kg, >25 kg)
  • a known difficult airway
  • risk of aspiration

研究组 & 干预措施

Supreme

Active Comparator

Supreme LMA

干预措施: Laryngeal Tube (Device)

Laryngeal Tube

Active Comparator

Laryngeal tube LTSII

干预措施: Supreme (Device)

Laryngeal Tube

Active Comparator

Laryngeal tube LTSII

干预措施: Laryngeal Tube (Device)

Supreme

Active Comparator

Supreme LMA

干预措施: Supreme (Device)

结局指标

主要结局

Oropharyngeal leak pressure

时间窗: 5 Min

Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).

次要结局

  • Fiberoptic position(5 Min)

研究者

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

ChristianKeller

PD Dr. med. M.Sc.

Schulthess Klinik

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