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临床试验/NCT01814306
NCT01814306Unknown不适用

Comparison of the Effectiveness Between the LMA SupremeTM and the LMA ProsealTM for Airway Management in Patient Undergoing Elective Orthopaedic Surgery in Prone Position

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Success rate of insertion (quality of ventilation)

研究概览

简要总结

There is no significant difference about success rate of two devices.

详细描述

There is no significant difference about success rate of two device: efficacy and safety

研究设计

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

入排标准

年龄范围
— 至 15 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •American Society Anesthesiologists physical status I-III
  • •Patient undergo elective orthopedics surgery in prone position under general anaesthesia

排除标准

  • •Age <15year
  • •Morbid obesity (BMI > 35kg/m2)
  • •Pregnancy
  • •Known or predicted difficult airway
  • •History of laryngeal problem (injury,subglottic stenosis)
  • •Local pharyngeal problem (abscess,tumor)
  • •Poor dentation
  • •Pulmonary disease

研究组 & 干预措施

Supreme

Active Comparator

Supreme LMA

干预措施: Supreme LMA (Device)

Proseal

Active Comparator

Proseal LMA

干预措施: Proseal LMA (Device)

结局指标

主要结局

Success rate of insertion (quality of ventilation)

时间窗: 1 year

次要结局

  • Ease of insertion, Complication and Glottic seal pressure(1 year)

研究者

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

Chatchai Prechawai

Anesthesiology Department

Prince of Songkla University

研究点 (1)

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