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临床试验/CTRI/2022/04/042024
CTRI/2022/04/042024尚未招募不适用

A Comparative study of Laryngoscope guided and Blind insertion techniques of Laryngeal Mask Airway Proseal in Children

VMMC and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年4月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
Oropharyngeal Leak Pressure.

研究概览

简要总结

A prospective comparative interventional randomised study comparing Laryngoscope guided and blind insertion technique of Laryngeal Mask Airway Proseal in children of age 2-12 years undergoing elective surgery under General Anesthesia in total 160 children ,80 in each group. The results will be compared in terms of Oropharyngeal Leak Pressure, Fiberoptic Position scoring , Ease of insertion, Heamodyanmic Parameters, trauma (to lip, teeth, gums, tongue and oral cavity) , and postoperative adverse events (like sore throat ,hoarseness of voice, dysphasia)

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
2.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • The ASA 1/2 children of either gender in the age group of 2-12 years old scheduled for surgery under General Anesthesia.

排除标准

  • Patients with anticipated difficult airway, restricted mouth opening, recent upper respiratory tract infection, increased risk of regurgitation,aspiration, hiatus hernia, cervical spine disease, head and neck surgeries, syndromes affecting airway.

结局指标

主要结局

Oropharyngeal Leak Pressure.

时间窗: At 5 mins after insertion of LMA

次要结局

  • Oropharyngeal Leak Pressure, Fiberoptic Position Scoring,Ease of insertion Scoring, Heamodyanamic Parameters, any trauma, postoperative adverse events(At Baseline, before insertion of PLMA,at 1,3 and 5 mins after insertion of LMA)

研究者

发起方
VMMC and Safdarjung Hospital
申办方类型
Government medical college

研究点 (1)

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