跳至主要内容
临床试验/CTRI/2020/01/022942
CTRI/2020/01/022942尚未招募不适用

A randomized controlled trial comparing laryngoscopy grade with or without intubation pillow in the paediatric population.

CMC vellore1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年1月2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
68
试验地点
1
主要终点
Primary Outcome: Assessment of Cormack and Lehane grade of laryngoscopy

研究概览

简要总结

The study aimsto assess the role of intubation pillow versus no pillow in paediatricintubation by assessing the Cormack and Lehane Laryngoscopy grade. This will bea randomized controlled study where children between 5 to 12years of age whoare undergoing elective surgery requiring endotracheal intubation, who consentfor the study will be randomized into two groups. The laryngoscopy will be doneusing an intubation pillow in group 1 and without intubation pillow in group 2.

 Thelaryngoscopy will be performed by primary investigator, an anaesthetist, whohas done at least 50 paediatric intubations along with consultant who hasexperience in paediatric anaesthesia. The scopies will be compared and studywill be started if the scopies are similar 75% of the time.

 The child willbe premedicated with syrup Trichloryl 75mg/kg one hour before the start ofanaesthesia. A silicon teeth guard will be used to cover the teeth. The childwill be induced in theatre with Sevoflurane (MAC intubation of 1.3), Fentanyl 1to 2 microgram per kilogram, and atracurium 0.5 milligram per kilogram.  In children who allow an intravenous line,Propofol 1.5 to 2.5 milligram per kilogram will be used for induction of anaesthesiainstead of sevoflurane. Sevoflurane will be used to maintain anaesthesia.Laryngoscopy will be done using Macintosh Blade five minutes afteradministration of the muscle relaxant. The primary investigator will compareCormack and Lehane grade. For children between 5 to 9 years of age a 4 cmpillow will be used and for age group between 10 and 12, a 6cm pillow will beused.  This data will be thenanalyzed.  The study hypothesizes that ahead elevation using the intubation pillow will facilitate a betterlaryngoscopy grade when compared to the traditional head neutral technique.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Not Applicable

入排标准

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

入选标准

  • All children between age group of 5 to 12 years.
  • 2.ASA I and II 3.Normal neck movement.

排除标准

  • 1.No parental consent.
  • 2.Children less than 5 years of age or more than 12-year-old.
  • 3.ASA III or more 4.GCS less than 15 5.Limited neck extension 6.Craniofacial anomalies.

结局指标

主要结局

Primary Outcome: Assessment of Cormack and Lehane grade of laryngoscopy

时间窗: October 2020

次要结局

  • 1.Assessment of BURP (Backwards Upwards Rightwards Pressure) maneuver to improve laryngoscopy grade.(2.Assessment of POGO score (Percentage Of Glottic Opening))

研究者

发起方
CMC vellore
申办方类型
Private medical college

研究点 (1)

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