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临床试验/NCT03378154
NCT03378154已完成不适用

Intubation Success and Glottis Visualization With King Vision Video Laryngoscope as Compared to Conventional Laryngoscopes in Children < 1 Years: A Randomized Control Trial

Jawaharlal Institute of Postgraduate Medical Education & Research2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
2
主要终点
First attempt intubation success rate

研究概览

简要总结

The primary objective of this study is to find out whether the intubation success rates of Kingvision video laryngoscope is better than that of the conventional laryngoscopes in children < 1 year of age?

详细描述

Securing the airway by tracheal intubation is one of the most critical steps during administration of general anesthesia to infants. Failure or a delay in tracheal intubation leads to severe hypoxic insult to infants as the oxygen consumption is high in them when compared to adults.Smaller caliber of the pediatric airway, relatively large tongue, anteriorly located larynx, floppy and relatively large epiglottis predispose young children to airway obstruction during Anaesthesia. In addition, the large occiput of the infant places the head and neck in the flexed position when the patient is placed recumbent, further exacerbating airway obstruction

Direct laryngoscopy requires a direct line of sight for proper glottis visualization which is achieved by proper alignment of airway axes (oral-pharyngeal-laryngeal). These manipulations can lead to significant hemodynamic disturbance, cervical instability, injury to oral and pharyngeal tissues and dental damage. In contrast to direct laryngoscopy, video laryngoscope utilizes indirect laryngoscopy via its camera and helps improve glottic visualization, thereby minimizing complications

New age videolaryngoscopes with their unique design provide better glottis visualization without the requirement of proper alignment of oral-pharyngeal-laryngeal axes, thereby minimizing the complications associated with excessive manipulation and hence provide a decent edge over the conventional indirect laryngoscopes routinely used. With the above mentioned advantages these videolaryngoscopes can be efficiently used in both elective as well as emergencysettings in infants for intubation The investigators in this study will be evaluating the efficacy of King vision video laryngoscope when compared to the conventional laryngoscopes in routine use for infants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
1 Day 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Patients of the age group 0-1 years undergoing elective or emergency surgeries belonging to American Society ofAnaesthesiologists(ASA) physical status classification 1-2 and requiring administration of General Anaesthesia with orotracheal intubation

排除标准

  • Patients with anticipated difficult airways
  • Patients with aspiration risk or requiring Rapid sequence induction (RSI)
  • Patients with laryngeal or tracheal pathologies
  • Cervical spine injury
  • Active respiratory infection or lung disease

结局指标

主要结局

First attempt intubation success rate

时间窗: 0 - 15 minutes

Comparison of first attempt intubation success rate of King vision videolaryngoscope and the Macintosh laryngoscope in children \< 1 year. A total of two laryngoscopy attempts each lasting not more than 60 secs will be allowed. Inability to secure the airway by means of successful orotracheal intubation within the 2 attempts will be taken as a failure. Success rates of both the devices will be compared in the study.

次要结局

  • Percentage of glottic opening score (POGO score)(0 - 15 minutes)
  • Mean intubation time(0 - 15 minutes)
  • Ease of insertion(0 - 15 minutes)
  • Cormack-Lehane grading (CL grade)(0 - 15 minutes)

研究者

发起方
Jawaharlal Institute of Postgraduate Medical Education & Research
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

M Manov

Principal investigator

Jawaharlal Institute of Postgraduate Medical Education & Research

研究点 (2)

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