跳至主要内容
临床试验/CTRI/2018/01/011136
CTRI/2018/01/011136已完成不适用

A Randomized Trial Comparing The Laryngeal Mask Airway Supremeâ„¢ With The Laryngeal Mask Airway Uniqueâ„¢ In Anaesthetised And Paralysed Children

Armed Forces Medical College1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2015年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
a.The ease of insertion

研究概览

简要总结

SUMMARY

In this study Laryngeal mask airway (LMA) Supreme was compared with LMA Unique in anaesthetised and paralysed children.The overall clinical performance of LMA Supreme was found superior to LMA Unique. LMA supreme was compared with LMA Unique in various parameters like airway leak pressure, ease of insertion, no of attempts and complications etc. It was found that LMA Supreme has a better ease of insertion less complications and larger airway leak pressure compared to LMA Unique.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
6.00 Month(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • •STUDY POPULATION Children undergoing elective day surgeries where a size 1.5,2 and 2.5 of LMA Unique will normally be used for airway maintenance will be enrolled in the study CRITERIA FOR SELECTION OF SUBJECTS
  • •ASA grade I and II.
  • •Age between 6 months and 8 years.

排除标准

  • •CRITERIA FOR EXCLUSION
  • •Patients with acute respiratory illness (cough, fever and rhinorrhea) on the day of anaesthesia
  • •Anticipated difficult airway.

结局指标

主要结局

a.The ease of insertion

时间窗: Airway leak pressure will me measured after the successful insertion of the device

c.Ease of gastric tube placement (in LMA Supreme)

时间窗: Airway leak pressure will me measured after the successful insertion of the device

2. Secondary outcome:

时间窗: Airway leak pressure will me measured after the successful insertion of the device

e.Complications

时间窗: Airway leak pressure will me measured after the successful insertion of the device

1. Primary outcome: Airway leak pressure.

时间窗: Airway leak pressure will me measured after the successful insertion of the device

b.Insertion success rate

时间窗: Airway leak pressure will me measured after the successful insertion of the device

d.Quality of airway patency

时间窗: Airway leak pressure will me measured after the successful insertion of the device

次要结局

  • 2. Secondary outcome:(a.The ease of insertion)

研究者

申办方类型
Government medical college

研究点 (1)

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