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临床试验/CTRI/2019/10/021616
CTRI/2019/10/021616尚未招募不适用

A randomized comparison of C-MAC video-laryngoscope and Macintosh laryngoscope blade for tracheal intubation in childrenfrom 1-24 months

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2019年1月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
106
试验地点
1
主要终点
1.Time for visualization of the glottis

研究概览

简要总结

Endotracheal intubation isconsidered the definitive airway for resuscitation and airway management.  The Macintosh laryngoscope is the mostcommonly used device, and is considered the gold standard for trachealintubation. Over the past decade, video laryngoscopes, based on the principleof indirect laryngoscopy, have become popular as an intubating device,especially in difficult airway scenarios.

The airway of an infant differsfrom older children and from adults. These critical anatomical differences andthe limited intubation time in infants due to higher oxygen consumption makeairway related events the most common perioperative critical incidents inpaediatric anaesthesia.

Several studies have shown thesuperiority of video laryngoscopes in adults over conventional laryngoscopes,in normal as well as difficult airway scenarios. The use of video laryngoscopeshas not been extensively studied in the paediatric population. Among the fewstudies done in paediatric population, video laryngoscopes have been shown toprovide better laryngeal views, however, time for intubation is more prolonged.

The C-MAC video laryngoscopeblade design is similar to the Macintosh, with the added advantage of a videocamera at the distal end of the blade. There are very few studies in childrencomparing C-MAC video laryngoscope with the conventional Macintoshlaryngoscope.

Therefore, this randomizedcontrol study is planned with the primary objective to compare time forendotracheal intubation with C-MAC video laryngoscope and a conventionalMacintosh laryngoscope.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
1.00 Month(s) 至 24.00 Month(s)(—)
性别
All

入选标准

  • Any ASA grade I and II patient aged 1 day to 1 year, presenting for elective surgery, after adequate fasting will be included in the study.

排除标准

  • Any patient with anticipated difficult airway, full stomach, conceptual age < 60 weeks, neuromuscular diseases, history of ICU stay, syndromic child or parental refusal is excluded.

结局指标

主要结局

1.Time for visualization of the glottis

时间窗: 1.Time taken from introduction of laryngoscope blade into oral cavity to visualization of the glottis | 2.Time taken from introduction of laryngoscope blade into oral cavity to passage of endotracheal tube past the vocal cords

2. Time for successful intubation

时间窗: 1.Time taken from introduction of laryngoscope blade into oral cavity to visualization of the glottis | 2.Time taken from introduction of laryngoscope blade into oral cavity to passage of endotracheal tube past the vocal cords

次要结局

  • 1.Incidence of trauma(2POGO score,)

研究者

申办方类型
Private medical college

研究点 (1)

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