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临床试验/CTRI/2025/09/095368
CTRI/2025/09/095368尚未招募4 期

Comparison of C-shaped with Hockey stick shaped stylet for endotracheal intubation in neonates and infants using miller blade videolaryngoscope

Vardhman Mahavir medical college and Safdarjung hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年10月5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
130
试验地点
1
主要终点
To compare C-shaped with Hockey stick shaped stylet for endotracheal intubation in neonates and infants using C-MAC Miller videolaryngoscope in terms of ETT Placement time, the time from obtaining the best glottic view till the passage of endotracheal tube into the glottis up to the desired depth.

研究概览

简要总结

Endotracheal intubation is a pivotal step in securing the airway in paediatric patients. Anatomical and physiological differences render the paediatric airway more challenging compared to adult population. These differences are more pronounced in neonatal age group and infancy. Owing to high oxygen consumption and small functional residual capacity, they are more susceptible to hypoxemia.

Though videolaryngoscopy offers a remarkable glottic view, negotiating the endotracheal tube through the glottis can be arduous. The ETT may repeatedly strike the posterior part of glottis or abut against the anterior tracheal wall causing difficulty in advancing it into the trachea. Optimizing the shape of ETT using a stylet has been shown to improve the success rate of intubation with videolaryngoscopy. Various shapes of the stylet have been utilized for intubation with a videolaryngoscope. Though studies in adult patients suggest the use of hockey stick shaped configuration as the preferable shape, there is a paucity of literature regarding the appropriate stylet shape when used for neonates and infants during videolaryngoscopy.12 Hence, we planned this study comparing C-shaped versus Hockey stick shaped stylet for endotracheal intubation in neonates and infants using Miller blade videolaryngoscope.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 12.00 Month(s)(—)
性别
All

入选标准

  • Children less than 12 months of age for surgery under general anaesthesia requiring endotracheal intubation Patients those who are classified as Grade 1 and 2 according to American Society of Anaesthesiologists Physical Status.

排除标准

  • Patients with anticipated difficult airway Patients with upper respiratory tract infections.

结局指标

主要结局

To compare C-shaped with Hockey stick shaped stylet for endotracheal intubation in neonates and infants using C-MAC Miller videolaryngoscope in terms of ETT Placement time, the time from obtaining the best glottic view till the passage of endotracheal tube into the glottis up to the desired depth.

时间窗: It is assessed intraoperatively after induction of general Anaesthesia during attempt at endotracheal intubation

次要结局

  • Time to glottic visualization using Miller blade Videolaryngoscope(Incidence of successful intubation in first attempt in less than 30 seconds)

研究者

发起方
Vardhman Mahavir medical college and Safdarjung hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Subash R

Vardhman Mahavir medical college and Safdarjung hospital

研究点 (1)

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