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临床试验/NCT03908411
NCT03908411已完成不适用

The Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy : a Randomized Controlled Trial

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年9月5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
入组人数
140
试验地点
2
主要终点
Cormack-Lehane grade

研究概览

简要总结

Paratracheal pressure may have a role in the prevention of pulmonary aspiration. The effects of paratracheal pressure on glottic view, ease of facemask ventilation, or tracheal intubation are not studied yet. In this study, the subjects are divided into two groups (group I: paratracheal pressure applied during induction of anesthesia, group II: conventional Sellick's maneuver applied during induction of anesthesia). Investigators will assess the glottic view during direct laryngoscopy.

详细描述

Primary outcome:

-Cormack-Lehane grade

Secondary outcome:

  • POGO score before and after application of each intervention
  • Difficulties of mask ventilation after application of each intervention
  • Inspiratory pressure and tidal volume during manual mask ventilation
  • Rates of worsening of the glottic view after intervention
  • The difficulty of endotracheal intubation
  • 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
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •Adult patient undergoing elective surgery with general anesthesia

排除标准

  • •A patient who does not agree to participate in this study A patient who has a history of cervical/esophageal operation A patient who has a risk of gastric regurgitation A patient who has atherosclerosis of the left carotid artery or history of stroke or angina in 3 months.

研究组 & 干预措施

Paratracheal pressure

Active Comparator

Left Paratracheal pressure is applied by ultrasound transducer after confirmation of the location of the esophagus.

干预措施: Paratracheal pressure (Procedure)

Sellick's maneuver

Active Comparator

Conventional Sellick's maneuver is applied.

干预措施: Sellick's maneuver (Procedure)

结局指标

主要结局

Cormack-Lehane grade

时间窗: During anesthesia induction procedure

Cormack-Lehane grade

次要结局

  • POGO(During anesthesia induction procedure)
  • Difficulty of mask ventilation(During anesthesia induction procedure)
  • Inspiration pressure(During anesthesia induction procedure)
  • Tidal volume(During anesthesia induction procedure)
  • Intubation difficulty(During anesthesia induction procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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