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临床试验/NCT05143346
NCT05143346已完成不适用

A Comparison Between Using Video Stylet and Video Laryngoscope in Difficult Intubation of Traumatic Patients .

Assiut University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年10月1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
66
试验地点
2
主要终点
Comparison of success rate for the tracheal intubation in patients with anticipated difficult airways, demonstrating the non inferiority of video stylet efficacy compare to the most consolidated technique based on videolaryngoscope

研究概览

简要总结

The aim of this study is to compare the visualization of the glottis, the time for tracheal intubation, the success rate of intubation, and the need for manoeuvres to optimize the view using video stylet or video laryngoscope in patients with expected difficult intubations.

详细描述

The airway, breathing and circulation support '' ABCs" of trauma resuscitation were born from the assumption that correcting hypoxemia and hypotension reduces morbidity and mortality. Definitive care for severely injured or polytrauma patients includes the ability to provide advanced airway management in a variety of settings: in the emergency department, 20% to 30% intubations are for trauma. Airway management in traumatic patient presents numerous unique challenges beyond placement of an endotracheal tube, without comes dependent on the provider's ability to predict and anticipate difficulty and have a safe and executable plan. In severely injured patients, the cervical spine must be protected by in-line immobilisation during airway management. If orotracheal intubation is required, then manual in-line stabilisation is recommended to facilitate tracheal intubation to secure a space for tongue displacement into the submandibular space. However, manual in-line stabilisation can make alignment of the oral, pharyngeal and laryngeal axes difficult, resulting in a poor direct laryngoscopic view and prolonging the intubation time. Video stylets, which are portable and easier to prepare than flexible fiberoptic bronchoscopes, could be better option for tracheal intubation in patient with cervical immobilization. Previous studies have shown the usefulness of video stylets for tracheal intubation in cervical immobilized patients.

Video laryngoscopes provide a better laryngeal view. They are easy to use and have a high success rate and short intubation time in patients with predicted difficult airways. Successful use of video laryngoscopy is increasing for airway management of patients with trauma in the emergency department.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
5 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient in the age group of (5 - 80) and has
  • Suspected difficult intubation.
  • High mallampati score (class 111, 1V).
  • Suspected cervical fracture.
  • Maxillofacial trauma.
  • Fracture base of the skull.
  • Polytrauma.

排除标准

  • Patients with low mallampati score (class 1, 11).
  • Patients undergoing elective surgeries and not suspected to have difficult intubations.
  • Patients aged below 5 years and above 80 years.

结局指标

主要结局

Comparison of success rate for the tracheal intubation in patients with anticipated difficult airways, demonstrating the non inferiority of video stylet efficacy compare to the most consolidated technique based on videolaryngoscope

时间窗: 5 minutes

The success rate of the rigid fiberoptic stylet to perform tracheal intubation in patients with anticipated difficult airways \[ Time Frame: up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 3 minutes) \] . success rate of the procedure defined as correct positioning of the tracheal tube in the trachea confirmed both endoscopically and through the capnographic curve end tidal carbon dioxide (Et CO2) time consumed to achieve a successful intubation by each device.

次要结局

  • Average time of intubation procedure expressed in seconds [ Time Frame: up to 3 minutes ](3 minutes)
  • Development of any complications [ Time Frame: up to 6 hours measured from the insertion of the device ](6 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

WTMahran

Doctor

Assiut University

研究点 (2)

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