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临床试验/CTRI/2024/02/062678
CTRI/2024/02/062678尚未招募4 期

A comparative study of Kingvision and VL3R (Hugemed)tm videolaryngoscope for the ease of intubation in adult patients undergoing general anaesthesia for elective surgery

JNMC hospital, Aligarh1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年3月4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
70
试验地点
1
主要终点
To compare the time for successful intubation for both the devices

研究概览

简要总结

Video assisted laryngoscope have a monitor that allows physicians to secure the airway under vision and additionally capture pictures and videos in real time, Indirect visualization of the laryngeal inlet provided by the newly designed video assisted laryngoscope facilitates tracheal intubation .

 To obtain optimal visualisation of the glottis, direct laryngoscopy requires alignment of the oropharyngeal-laryngeal axes. However, duration of intubation and the success rate for securing the airway by tracheal intubation might have a significant impact on undesirable events like hypoxia or regurgitation. It can sometimes be challenging to place an endotracheal tube (ETT) in front of the glottis and advance it despite good visualization on the monitor, especially when a video laryngoscope (VL) with a hyper-angulated blade is used. This phenomena (great view but unable to intubate) is linked to VL blades that are, unlike the traditional Macintosh blade, hyperangulated. Because of the unique profile that follows the anatomical shape of the human airway, alignment of the oropharyngeal-laryngeal axes becomes unnecessary to visualize the glottis.

 The new challenge is now to also bring the tip of the ETT to the level of the glottis, pass the glottis and advance the tube inside the trachea. Several techniques have been proposed to meet this challenge; many authors proposed using a stylet to give the tube the shape of a “hockey stick” to follow the curvature of the video blade. However, ETT placement is often associated with a prolonged time for intubation. Additionally, stylet use for video laryngoscopy has been linked to an increased risk of soft tissue injury of the upper airway.

 The success of a Videolaryngoscope assisted intubation depends on multiple factors, such as blade design (acute angled or Macintosh like; channeled or non-channeled); quality of the image on the monitor, as well as the experience of the intubator .

 Hence we hypothesize from above findings that for the same reasons mentioned in above studies, perhaps we may have an alternative device in the form of HugeMed  VL3 ,which could be comparable to the king vision non channeled device in terms of easy and quick intubation time.

 Therefore, the present study is aimed at comparing the VL3 videolaryngoscope and the king vision video larygnoscope,  in terms of airway management times, performance indices, hemodynamics and complications, if any, in adult patients scheduled for elective surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Written and well informed consent.
  • ASA grade I-II of either sex.
  • All Mallampatti grades.
  • Age between 18-60 years.
  • Weight between 45-70 Kg.

排除标准

  • 1.ASA grade III and IV
  • Previous failed intubations
  • Head and neck surgery
  • Pregnancy
  • Inter incisor distance less than 3 cm
  • Risk of gastric regurgitation ( full stomach, hiatus hernia)
  • Raised ICP or cervical spine injury.

结局指标

主要结局

To compare the time for successful intubation for both the devices

时间窗: at first capnograph reading

次要结局

  • Change in haemodynamic parameters(pre insertion, immediately post insertion, 3 minutes, 5 minutes, 10 minutes)
  • Ease of intubation(At end of intubation)

研究者

发起方
JNMC hospital, Aligarh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Trisha Kshirsagar

Jawaharlal Nehru Medical College, Aligarh

研究点 (1)

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