跳至主要内容
临床试验/NCT04973176
NCT04973176已完成不适用

Standard Versus Flexible Tip Bougie for Videolaryngoscopy: A Randomised Comparison Between Standard and Flexible Tip Bougie (Tracheal Tube Introducers) for Tracheal Intubation Using Non Channelled Videolaryngoscope

University Hospitals Coventry and Warwickshire NHS Trust2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
Modified Intubation Difficulty Scale Score (mIDS)

研究概览

简要总结

This study aims to compare the flexible tip bougie with standard bougie for tracheal intubation using non channelled, acute angled video laryngoscope using modified intubation difficulty scale score as primary outcome.

详细描述

Videolaryngoscopes are devices which aid successful intubation of the trachea. Unlike standard (direct) laryngoscopes, they include a camera at the tip of the blade and display unit to provide an indirect view of the vocal cords (glottis). They are now routinely used for both standard and anticipated difficult tracheal intubation, and are recommended for difficult intubation in UK national guidelines.

Some videolaryngsocopes have a channel as a guide to help with placement of a tracheal tube and some are without a channel. The non-channelled videolaryngoscopes with acute-angled blades require a bougie or stylet to facilitate the passage of a tracheal tube through the glottis into the trachea.

One problem commonly encountered when using a standard bougie, is the tip of the bougie abutting on the anterior part of glottis and entrance to the windpipe (trachea) and not advancing further into the trachea. This is known as anterior impingement. This can increase the likelihood of repeated intubation attempts, failed intubation and airway trauma. C-Mac is a commonly used non-channelled videolaryngoscope and has been shown to have high first attempt success rate as compared to other videolaryngoscopes, however, the acute angled D-blade requires a bougie to facilitate tracheal intubation.

The recently introduced flexible tip bougie is likely to overcome the problem of anterior impingement, due to the ability to flex the tip in the posterior direction once the tip enters the glottis. Comparing the efficacy of these devices could help inform anaesthetists' decisions in the future when faced with a potentially difficult airway.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged above 18, presenting for elective surgical procedures and requiring general anaesthesia tracheal intubation.

排除标准

  • Patients who are do not want to take part or do not give consent
  • Patients below 18 years of age
  • Patient physical status of ASA 4 and 5,
  • Patients deemed to require awake intubation

结局指标

主要结局

Modified Intubation Difficulty Scale Score (mIDS)

时间窗: average 1 minute

Composite score of difficulty of tracheal intubation using the bougie devices minimum score is zero, maximum possible score is 10, higher values represent worse outcome. Total score is sum of sub scales, values are numbers Total 6 sub scale from N1 to N6 ( N1: 0-2, N2: 0-1, N3:0-5, N4: 0-1, N5 0-1, N6 0-1, so total mIDS score is sum of N1 to N 6 sub scales)

次要结局

  • Time to Successful Tracheal Intubation(less than two minutes)
  • Laryngoscopy Time(less than one minute)
  • Overall First Attempt Success Rate(average 1 minute)
  • Anaesthetist's Visual Analogue Score for Ease of Use of the Bougie(average 1 minute)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验