跳至主要内容
临床试验/NCT04135651
NCT04135651已完成不适用

Effect of Paratracheal Esophagus Pressure on the Endotracheal Intubation With Pentax Airway Scope

Ajou University School of Medicine2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2019年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
2
主要终点
Time to intubation

研究概览

简要总结

Recently, left paratracheal pressure was introduced as an alternative method to prevent pulmonary aspiration instead of cricoid pressure. Criocoid pressure is known to worsen glottic visibility when using Pentax.However, the effects of left paratracheal pressure on glottic view when using Pentax are not studied yet. In this study, the subjects are divided into two groups (group I: left paratracheal pressure applied before intubation, group II: conventional cricoid pressure applied before intubation). Investigators will assess the glottic view during intubation using Pentax.

详细描述

Primary outcome

  • Duration of intubation

Secondary outcomes

  • POGO (percentage of glottic opening) score before and after application of each intervention
  • Glottic grade by Cormack Lehane
  • The success rate in first attempt
  • Intubation difficulty scale
  • Hemodynamics during intubation
  • Postoperative airway complications

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The group assignments were sealed in opaque envelopes by a research assistant not involved in the study.

The interventional process covers opaque clothes.

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are undergoing surgery under general anesthesia
  • American Society of Anesthesiologists Classification 1-2

排除标准

  • Body mass index > 35 kg/m2
  • High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
  • Criteria for difficult airway (limitation of mouth opening/neck extension, Mallampati class IV),

结局指标

主要结局

Time to intubation

时间窗: During anesthesia induction procedure

The duration from when Pentax pass the tooth to confirm the successful intubation using capnography

次要结局

  • The percentage of glottic opening (POGO) score(During anesthesia induction procedure)
  • Cormack-Lehane grade(During anesthesia induction procedure)
  • Postoperative complications(An average of 1 hours after extubation)
  • Intubation difficulty scale (IDS)(During anesthesia induction procedure)
  • Intubation difficulty by NRS score(During anesthesia induction procedure)
  • Success rate in first attempt(During anesthesia induction procedure)
  • Hemodynamic changes(During anesthesia induction procedure)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Yeop Kim

Professor

Ajou University School of Medicine

研究点 (2)

Loading locations...

相似试验