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临床试验/CTRI/2024/10/074918
CTRI/2024/10/074918尚未招募4 期

Comparison of new generation Baska mask with LMA Protector in elective surgery under general anaesthesia: A Randomized Controlled trial

AIIMS Gorakhpur1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To compare oropharyngeal seal pressure (OLP) while using LMA ProtectorTM and Baska mask at various time intervals

研究概览

简要总结

Since the LMA ProtectorTM was introduced as the most advanced second generation of LMA devices, and studies has shown its superiority in terms of orppharyngeal leak pressure as compared to other second generation devices3. Whereas various studies have shown that the oropharyngeal seal formed by the baska mask is superior when compared to other supraglottic devices used commonly these days. However there is no study comparing these two so we wanted to evaluate oropharyngeal leak pressure among these two new devices.In this study we aim to compare the Baska mask with the LMA ProtectorTM in terms of quality of insertion, quality of ventilation and incidence of post-operative complications

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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

  • ASA I and II, who are scheduled for routine elective surgeries under general anaesthesia.

排除标准

  • Patient’s refusal, difficult airway, High Body mass index Patients with neck pathology Pregnant females, Patients at increased risk of gastric aspiration.
  • laparoscopic surgery Emergency surgery.

结局指标

主要结局

To compare oropharyngeal seal pressure (OLP) while using LMA ProtectorTM and Baska mask at various time intervals

时间窗: To compare oropharyngeal seal pressure (OLP) at 10, 20, 30, 60 minutes interval

次要结局

  • To compare the ease of insertion of each device in terms of time taken and number of attempts per device insertion.

研究者

发起方
AIIMS Gorakhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

sonam patel

AIIMS gorakhpur

研究点 (1)

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