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临床试验/CTRI/2024/07/069727
CTRI/2024/07/069727尚未招募Unknown

Comparison of the performance between channelled and unchannelled blades of king visionâ„¢ videolaryngoscope in simulated rapid sequence induction of anaesthesia- a randomized controlled trial

University college of medical sciences and GTB hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年7月11日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Time taken for intubation through King Vision channelled blade Videolaryngoscope and King Vision Unchannelled blade Videolaryngoscope

研究概览

简要总结

Rapid sequence induction (RSI) is an anaesthetic technique indicated in  patients who have an increased risk of gastric regurgitation and aspiration.The objective of this technique is to minimize the most critical period i.e. when aspiration of gastric content may occur.

Videolaryngoscopy offers better glottic view as it does not require alignment of three axes i.e. oral, laryngeal and pharyngeal into one plane.On literature search, we observed that various VLs like CMAC, PENTAX, CVS, Airtraq and Channelled King Vision have been evaluated for facilitating intubation in RSI We hypothesize a higher performance of channelled VL when compared to unchannelled VL in terms of decreased time to intubation and better glottic view in RSI.On Literature search, we could not retrieve any study evaluating and comparing of the performance between channelled and unchannelled blades of King Vision videolaryngoscope in simulated rapid sequence induction of anaesthesia in patients scheduled for elective surgeries in Surgery and Gynaecology Operation theatre. Patients of either sex, aged 18-65yr, ASA grade I/II, with Modified Mallampati grade I/II, mouth opening >3cm, BMI<30 kg/m2 scheduled for elective surgeries under general anaesthesia and Exclusion criteria are Obstetric patients,Anticipated difficult airway [e.g. unanticipated difficult airway in the medical history (e.g.,Cormack and Lehane (C&L) ≥ III) or Airway Difficulty Score >8. Patient will be allocated into one of the two groups. Patients in group CB  will undergo laryngoscopy using channelled blade of King Vision VL. Patients in Group UB  will undergo laryngoscopy using unchannelled blade of King Vision VL. The primary outcome is to compare the Time taken for intubation between the two groups

Secondary outcomes are Cormack-Lehane grade of laryngeal view,POGO Score (percentage of glottic opening),No. of intubation attempts,Hemodynamic parameters i.e. HR,SBP,DBP and MAP during laryngoscopy,Intubation difficulty score,Ease of Intubation,Complications i.e.desaturation,laryngospasm etc.

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 65.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I and II with Modified Mallampati grade I and II with mouth opening more than 3cm with BMI less than 30 kg per m2 scheduled for elective surgeries under general anaesthesia.

排除标准

  • 1 Obstetric patients 2 Anticipated difficult airway example unanticipated difficult airway in the medical history for example Cormack and Lehane grade more than or equal to III or Airway Difficulty Score more than 8.

结局指标

主要结局

Time taken for intubation through King Vision channelled blade Videolaryngoscope and King Vision Unchannelled blade Videolaryngoscope

时间窗: Once,from inserting the Videolaryngoscope into the oral cavity till the confirmation of endotracheal intubation by using square wave form capnography in monitor

次要结局

  • 1 CL grade of laryngeal view(2 POGO Score)

研究者

发起方
University college of medical sciences and GTB hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Yogesh Kumar

University college of medical sciences and GTB Hospital Dilshad Garden Delhi

研究点 (1)

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