跳至主要内容
临床试验/CTRI/2023/03/051160
CTRI/2023/03/051160已完成不适用

Comparison of fibreoptic guided tracheal intubation through LMA protector and i-gel in adult paralysed patients

Department of anaesthesiology and critical care1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月31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
60
试验地点
1
主要终点
Fibreoptic guided total tracheal intubation time

研究概览

简要总结

Providing a safe airway is the prime responsibility of an anaesthesiologist. Supra glottic airway devices (SAD) are being widely used for airway management in the anaesthetic field, critical care and emergency situations. Since the introduction of the first generation classic laryngeal mask airway (cLMA), the evolution in supraglottic airway designs has been a continuous process. Second generation SADs incorporate a second drainage tube to enhance the safety of supraglottic airway devices. In current scenario they are not only used as a ventilating device but also act as conduit for planned blind as well as fiberoptic guided intubation in anticipated or unanticipated difficult laryngoscopies.i-gel (Intersurgical, Berkshire, UK) is a promising second-generation SAD which has gained popularity over last decade because of its anatomical shape and gel filled cuff. The airway channel of i-gel is shorter and wider compared to that of the other SADs, allowing the adult size endotracheal tube to easily pass through it. Its large bowl, better alignment with glottis along with the absence of aperture bars makes i-gel a favorable conduit for fibreoptic-guided tracheal intubation. The LMA Protector (Teleflex Medical Europe Ltd., Athlone, Ireland) is a recently introduced, second-generation SAD with design features that minimizes the risk of gastric aspiration. In comparison to the i-gel, there are two gastric drainage tubes on either side of the ventilation channel and an enlarged air inflatable cuff.In addition,the airway lumen of the LMA Protector is wide enough to pass an adequately sized tracheal tube. Hence, LMA Protector can be used as a conduit for fibreoptic-guided tracheal  intubation.As there is no previous randomized trial primarily comparing fibreoptic-guided tracheal intubation via the LMA Protector with i-gel using polyvinyl chloride ( PVC ) endotracheal tube. So, we planned the current study to compare fibreoptic-guided tracheal intubation through the i-gel with the LMA Protector using PVC ETT.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex from age 18 to 70 years belonging to American society of anaesthesiologists (ASA) physical status1 or 2 scheduled for elective surgery under general anaesthesia will be included.

排除标准

  • Patients with Anticipated difficult airway BMI >35kg/sq.meter Inter incisor distance of <3.2 cm Pregnancy Known gastro esophageal reflex Upper airway pathology Surgical procedures involving oral cavity or in prone position Recent upper respiratory tract infection Patients refusal.

结局指标

主要结局

Fibreoptic guided total tracheal intubation time

时间窗: At 0 minute, before start of surgery at the time of anaesthesia induction

次要结局

  • Mean time of insertion(Ease of insertion)

研究者

发起方
Department of anaesthesiology and critical care
申办方类型
Government medical college

研究点 (1)

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