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临床试验/NCT03808896
NCT03808896Unknown不适用

Taipei City Hospital ZhongXing Branch, Emergency Department

Taipei City Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
first pass success rate

研究概览

简要总结

In the previous study on mannekin, the investigators found stylet-assisted lifting of epiglottis is an useful technique on difficult airway (Cormack-Lehane grade IIIa, IIIb) without increasing subjective difficulty. It has no expenses other than the routine intubation process. Recently, the studies have proved that the bougie-assisted laryngoscopy can improve first pass intubation rate in the emergency department. However, bougie is a disposable device and may increased medical expenditure. The investigators will evaluate the safety of bougie and epiglottic lifting technique, as well as the first pass and overall success rate of intubation comparing to traditional video laryngoscopy and direct laryngoscopy.

详细描述

A better strategy of managing Cormack-Lehane Grade III had been investigated by our previous study. The investigators' research results had been accepted and published by the journal BioMeidcal Central Anesthesiology. The investigators will be eager to do the further clinical trial to investigate the impact of this technique clinically. Besides, bougie assisted intubation is a effective, evidenced-proved intervention. The investigators will also like to find out the prognosis differences between these two techniques.

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, Investigator)

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

  • all the patients present to the emergency department with airway emergency who need intubation

排除标准

  • age below 18 year-old

研究组 & 干预措施

bougie-assisted intubation

Active Comparator

use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy

干预措施: bougie-assisted intubation (Device)

intubation with epiglottic lifting

Active Comparator

Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy

干预措施: stylet-assisted epiglottic lifting (Procedure)

Traditional intubation

No Intervention

intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited

结局指标

主要结局

first pass success rate

时间窗: through the intubation period, an average of 90 seconds

first pass sucess rate

duration of intubation

时间窗: through the intubation period, an average of 90 seconds

次要结局

  • Immediate complications direct related to intubation process(through the intubation period, an average of 90 seconds)
  • Overall success rate(within 48 hours of intubation)

研究者

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

Hung,Tzu-Yao

Director of emergency department

Taipei City Hospital

研究点 (2)

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