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临床试验/NCT03841890
NCT03841890已完成不适用

The Clarus Video System (Trachway) and Direct Laryngoscope for Endotracheal Intubation With Cricoid Pressure in Simulated Rapid Sequence Induction Intubation: A Prospective Randomized Controlled Trial

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年11月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
The first attempt success rate

研究概览

简要总结

During an emergency endotracheal intubation, rapid sequence induction intubation with cricoid pressure is frequently implemented to prevent aspiration pneumonia. When properly applied, cricoid pressure may not affect glottic view during endotracheal intubation with either a direct laryngoscope or a video laryngoscope. However, the application of cricoid pressure is likely to prolong the intubation time. Limited mouth opening or vulnerable teeth, which often accompany the patients requiring emergency intubation, are the two common factors to deter the intubators from using a laryngoscopic device. Besides, the blade of a laryngoscopic device is often too bulky for a narrow mouth opening, and the blade always bears a level force on upper incisors while the intubator is lifting epiglottis during intubation, which is liable to tooth fracture. In this prospective randomized study, the investigators compare the use of the Clarus Video System and that of direct laryngoscope (Macintosh Laryngoscope) in patients undergoing endotracheal intubation in simulated rapid sequence induction intubation for the primary goals of the first attempt success rate and intubation time.

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)

盲法说明

Sore throat and mucosa injury are documented by a blinded observer on the next day.

入排标准

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

入选标准

  • Older than 20 years of age
  • Scheduled for elective surgery under general anesthesia

排除标准

  • BMI (Body Mass Index) > 35 kg/m2
  • Interincisor distance < 3 cm
  • Poor dentition
  • Upper airway tumor
  • Limited neck mobility
  • Pregnancy
  • History of difficult tracheal intubation

研究组 & 干预措施

Intubation with the Clarus Video System as a video stylet

Experimental

干预措施: the Clarus Video System as a video stylet (Device)

Intubation with the Clarus Video System as a lightwand

Experimental

干预措施: the Clarus Video System as a lightwand (Device)

Intubation with direct laryngoscope

Active Comparator

干预措施: direct laryngoscope (Device)

结局指标

主要结局

The first attempt success rate

时间窗: After intubation immediately

Intubation time

时间窗: After intubation immediately

Intubation time was counted from the inserting the device into the patient's mouth to viewing the endotracheal tube into the trachea.

次要结局

  • Blood pressure(1 minute and 5 minutes after intubation)
  • Sore throat(On postoperative day 1)
  • Mucosal injury(On postoperative day 1)
  • Heart rate(1 minute and 5 minutes after intubation)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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