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临床试验/CTRI/2025/03/081877
CTRI/2025/03/081877已完成不适用

Clinical performance of I-gel and I-gel plus for airway management of obese patients: a prospective randomised controlled study

Dr Farhan Zahir Shaikh1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
Oropharyngeal leak pressure

研究概览

简要总结

Clinical performance of I-gel and I-gel plus for airway management of obese patients: A prospective randomised controlled study

INTRODUCTIONObesity has emerged as a global health concern, and its prevalence continues to rise, presenting unique challenges in various medical contexts, particularly during anesthesia and surgery.[1] Airway management in obese patients poses distinct difficulties due to altered anatomy, increased adipose tissue, and a higher prevalence of comorbid conditions such as obstructive sleep apnea. As such, there is a growing need for effective and safe airway management strategies tailored to this specific population.Clinical performance of I-gel and I-gel plus for airway management of obese patients: a prospective randomised controlled study I-gel is a new supraglottic airway device designed to fit the peri-laryngeal and hypo-pharyngeal structures without the use of an inflatable cuff, made of a thermoplastic elastomer (styrene ethylene butadiene styrene) with a soft durometer (hardness) and gel like, provides a seal in patients with a wide range of anatomical variation. The claimed potential advantages include ease of insertion and use with minimal tissue compression and congestion, airway complications and stability following insertion. The I-gel is a second-generation supraglottic airway device designed to provide a non-invasive means of securing the airway. A previous anatomical study in cadavers has shown that the I-gel™ is capable of achieving a good peri-laryngeal seal without the requirement for an inflatable cuff.[2]

It also has features designed to allow a gastric tube to be passed into the stomach. The anatomically shaped non inflatable cuff may be responsible for higher oropharyngeal leak pressure that suggests better safety and provide positive pressure ventilation.[3]

Several studies have investigated the role of the I-gel in obese patients. Here are references to some of these studies- Prabha et al compared I-gel for general anesthesia in obese and nonobese patients.[4] In this study they concluded that i-gel is as effective in obese patients as in nonobese patients when used for securing the airway for surgical procedures.Singh et al did a comparative evaluation of ProSeal laryngeal mask airway, I-gel and Supreme laryngeal mask airway in adult patients undergoing elective surgery a randomised trial study.[5] They found that PLMA provides better sealing pressure but takes longer to insert. I-gel and SLMA have similar sealing pressures. I-gel insertion time is quicker.

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

  • Obesity (BMI greater than or equal to 30 KG/m2) ASA physical Status II & III Elective surgery.

排除标准

  • Pregnancy Inter-incisor gap Head and neck surgery Respiratory and cardiovascular disease Refusal to give consent.

结局指标

主要结局

Oropharyngeal leak pressure

时间窗: One minute after confirmation of supraglottic airway device placement

次要结局

  • 1. Time taken for supraglottic airway device insertion(2. Success rate of insertion)

研究者

发起方
Dr Farhan Zahir Shaikh
申办方类型
Other [self-funded]
责任方
Principal Investigator
主要研究者

Farhan Zahir Shaikh

King Georges Medical University

研究点 (1)

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