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临床试验/NCT03089528
NCT03089528已完成不适用

Videolaryngoscopy Versus Direct Laryngoscopy for Tracheal Intubation in Patients With Diabetes Mellitus

Diskapi Teaching and Research Hospital2 个研究点 分布在 2 个国家目标入组 85 人开始时间: 2017年4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
85
试验地点
2
主要终点
first-attempt intubation success rate

研究概览

简要总结

The use of videolarygoscopy (VL) as first choice for tracheal intubation versus direct laryngoscopy (DL) is a matter of debate.

These two methods were compared in several studies. Videolaryngoscopes may reduce the number of failed intubations, particularly among patients presenting with a difficult airway. They improve the glottic view and may reduce airway trauma. DM is accepted as a risk factor for difficult intubation.

The aim of this study is to compare VL to DL in adult patients requiring tracheal intubation for anesthesia, in terms of intubation success, glottic view quality, intubation failure, intubation time, conversion to another laringoscopy method and adverse outcomes related to tracheal intubation.

详细描述

The use of videolarygoscopy (VL) as first choice for tracheal intubation versus direct laryngoscopy (DL) is a matter of debate.

These two methods were compared in several studies. First attempt intubation success and glottic visualization with VL versus DL by pediatric emergency medicine providers in simulated patients were evaluated and it was concluded that VL was associated with greater first-attempt success during intubation by pediatric emergency physicians on an adult simulator.

The ease of viewing the glottis under direct vision during conventional laryngoscopy with the quality of indirectly viewing on a monitor during laryngoscopy with a Macintosh videolaryngoscope was compared in a multicenter study. The results were that VL can lead to better viewing conditions but in rare cases it may result in worse viewing conditions.

The study evaluating the efficacy and safety of VL compared to DL in decreasing the time and attempts required and increasing the success rate for endotracheal intubation in neonates concluded that there was insufficient evidence to recommend or refute the use of VL for endotracheal intubation in neonates.

Diverse videolaryngoscopes where also compared in patients undergoing tracheal intubation for elective surgery: the GlideScope Ranger (GlideScope, Bothell, WA), the V-MAC Storz Berci DCI (Karl Storz, Tuttlingen, Germany), and the McGrath (McGrath series 5, Aircraft medical, Edinburgh, UK) and tested whether it is feasible to intubate the trachea of patients with indirect videolaryngoscopy without using a stylet. The authors concluded that the trachea of a large proportion of patients with normal airways can be intubated successfully with certain VL blades without using a stylet, although the three studied VL's clearly differ in outcome. The Storz VL displaces soft tissues in the fashion of a classic Macintosh scope, affording room for tracheal tube insertion and limiting the need for stylet use compared with the other two scopes. Although VL's offer several advantages, including better visualization of the glottic entrance and intubation conditions, a good laryngeal view does not guarantee easy or successful tracheal tube insertion.

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
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective surgery
  • Patients needing endotracheal intubation
  • Patients having diabetes mellitus

排除标准

  • Emergency surgery

结局指标

主要结局

first-attempt intubation success rate

时间窗: first second after intubation

successful intubation with the allocated device

intubation time

时间窗: 0-120 seconds after intubation

The time elapsed between the passage of the larygoscope through the teeth and the detection of ETCO2

intubation difficulty

时间窗: 0-12 seconds after intubation

number of attempts, number of operators, number of alternative techniques, CL grade, lifting force, laryngeal pressure, position of the vocal cords,

次要结局

  • the rate of conversion to another laryngoscopy method(5 seconds after the first attempt to intubate)
  • glottic view quality(during laringoscopy)
  • percentage of glottic opening(during laringoscopy)
  • adverse outcomes related to tracheal intubation.(1 minute after intubation)

研究者

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

DILEK YAZICIOGLU

Associate Proffesor

Diskapi Teaching and Research Hospital

研究点 (2)

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