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临床试验/CTRI/2021/12/038787
CTRI/2021/12/038787已完成不适用

Comparison of besdata video laryngoscope with direct laryngoscope in term neonates and infants upto 6 months of age- A randomized control trial

JIPMER1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年12月31日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
JIPMER
入组人数
80
试验地点
1
主要终点
To compare the time taken for successful tracheal intubation with Besdata video laryngoscope and Miller direct laryngoscope in term neonates and infants up to 6 months of age

研究概览

简要总结

The anatomy of airway in infants is significantly different than of adults. Multiple anatomic differences like large tongue, floppy epiglottis, more anterior situated larynx, large occiput, smaller diameter of the airway make direct laryngoscopy and intubation difficult. Also the anesthetised neonates and infants are prone for hypoxia even with minor delay in airway management.The conventional direct laryngoscopy though commonly used and successful is limited by the requirement of alignment of line of sight of anesthetist with axis of laryngoscopic inlet. Video laryngoscope whereas uses video camera for focused view over the laryngeal inlet thereby obviating the need of alignment of laryngeal axis. Due to better glottic visualization video laryngoscopy can reduce number of intubation attempts and first attempt intubation success rate.

Therefore in this study we compare direct laryngoscope using age appropriate size miller blade with besdata video laryngoscope using zero size miller blade in term neonates and infants upto 6 months of age. With this comparison if video laryngoscope is equivalent to direct laryngoscope,then based on the results of the study video laryngoscope can be used as an alternative to direct laryngoscope in emergency and elective pediatric intubation.

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
0.00 Day(s) 至 6.00 Month(s)(—)
性别
All

入选标准

  • Full term Neonates and infants upto 6 months with ASA class I and II requiring general anaesthesia with orotracheal intubation for any surgical procedure.

排除标准

  • Patients with increased risk of gastric regurgitation and aspiration (which includes patients with anomalies like congenital diaphragmatic hernia and intestinal obstruction) 2) Patients with congenital airway anomalies 3) Patients with anticipated difficult airway (which includes patients with hydrocephalus and syndromes with features like micrognathia and retrognathia) 4) Active upper respiratory tract infection.

结局指标

主要结局

To compare the time taken for successful tracheal intubation with Besdata video laryngoscope and Miller direct laryngoscope in term neonates and infants up to 6 months of age

时间窗: Baseline

次要结局

  • Time for best glottic visualization(Baseline)
  • To compare first attempt intubation success rate(NA)
  • To compare POGO Score (Percentage of Glottic opening) between the two groups(NA)
  • To assess for development of complications such as airway mucosal trauma, bradycardia, esophageal intubation.(NA)

研究者

发起方
JIPMER
申办方类型
Research institution and hospital

研究点 (1)

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