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临床试验/CTRI/2024/11/076236
CTRI/2024/11/076236招募中不适用

Comparison of three different techniques for the insertion of proseal laryngeal mask airway in adults- A prospective randomised clinical study

SHIMOGA INSTITUTE OF MEDICAL SCIENCES SHIMOGA1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年11月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Time taken for successful insertion of Proseal laryngeal mask airway

研究概览

简要总结

Need for the study:

The Proseal Laryngeal mask airway (PLMA) is a supraglottic airway device

commonly used in clinical practice for airway management during general anaesthesia.

It has been popular due to its ease of insertion, high success rate of insertion, and less

risk of invasive manipulation.

1

However, despite its widespread use, the standard technique for insertion of

Proseal LMA (PLMA) remains a topic of debate. The traditional insertion technique

involves the use of the index finger to place the PLMA into position, which can be

challenging in patients with limited mouth opening, large tongue, or short neck.

2

In

response to these challenges, various alternative techniques have been introduced,

including the 90° rotation technique and the use of metallic introducer.

3

The index finger technique involves using the index finger for introducing the

PLMA upto hypopharynx, allowing for better control and a smoother insertion.

4

The 90 degree rotation technique involves rotating the Proseal laryngeal mask

airway 90 degrees anticlockwise during insertion into oropharynx, which has been

shown to reduce the risk of epiglottic entrapment and improve the seal of the Proseal

LMA.

5

The metallic introducer technique is performed using a rigid metallic introducer

which guides the PLMA into position, which may be advantageous in patients with

difficult airway.

6

However, the insertion technique for the Proseal LMA is crucial for its successful

use, and there is currently no consensus on the most optimal technique. This has led to

the development of different techniques for Proseal LMA insertion, each with its own

advantages and disadvantages. Therefore, our study is proposed to compare the efficacy

of these three techniques and determine the most suitable approach for Proseal LMA insertion

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective surgeries that require general anaesthesia with Proseal Laryngeal mask airway 2.Age group of more than 18 years and less than 60 years of either sex 3.American society of anaesthesiologists (ASA) physical status 1 and 2.

排除标准

  • Age group of less than 18 years old and more than 60 years old of either sex
  • American society of anaesthesiologists (ASA) physical status 3 and 4.

结局指标

主要结局

Time taken for successful insertion of Proseal laryngeal mask airway

时间窗: From Picking up the Proseal laryngeal mask for insertion till adequate chest rise and ETCO2 graph

次要结局

  • Hemodynamic changes during insertion of Proseal laryngeal mask airway with three different techniques(1)Basal vitals before insertion of Proseal laryngeal mask airway)

研究者

发起方
SHIMOGA INSTITUTE OF MEDICAL SCIENCES SHIMOGA
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr PRATYUSHA

Shimoga institute of medical sciences

研究点 (1)

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