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临床试验/NCT04520581
NCT04520581Unknown不适用

The Use of "O" Shaped- Endotracheal Tube During Intubation for General Anesthesia: Prospective Randomized Trial

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2020年3月24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
238
试验地点
1
主要终点
First intubation success rate for each between two group

研究概览

简要总结

This study is prospective randomized trial study. "O" type tracheal intubation tube is anatomically consistent and will able to increase the success rate of first intubation without any other external help.

详细描述

This study is divided into two groups. : control vs. "O" shape endotracheal tube.

The investigator was studied 238 consecutive the American Society of Anesthesiologists' physical grades I and II adult patients scheduled to undergo general anesthesia requiring tracheal intubation for elective surgery. Exclusion criteria included a gross anatomical abnormality, before surgery of the head, neck and cervical spine, previously difficult tracheal intubation, loose teeth, or those requiring a rapid sequence or awake intubation, moderate or severe obstructive/restrictive pulmonary disease accompanied by pulmonary function tests. Anesthesia was induced with remifentanyl 3ng/kg, propopol 1-2 mg/kg or TIVA 2% fresopol 4ug/dL, remifentanyl 3ng/dL and rocuronium 0.8 mg/kg to facilitate tracheal intubation. Laryngoscopy was performed after the loss of the fourth twitch in the train-of-four in response to ulnar nerve stimulation. All laryngoscopies using a #4 Macintosh blade were performed with the patient placed in the sniffing position. Tracheal intubation was performed without assistance (ex. External laryngeal manipulation, Used stylet). A single experienced anesthesiologist, blinded to each group, performed all of the direct laryngoscopies and classified the laryngoscopic view according to the modified Cormack and Lehane grade, measured number of attempts, intubation time and blood pressure and heart rate before/ after intubation.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Consented to participate in the study
  • Aged 19 years or older
  • The American Society of Anesthesiologists' physical grades I and II
  • Undergo elective surgery under general anesthesia

排除标准

  • Do not agree to participate in research
  • Previously difficult tracheal intubation
  • Rapid induction of anesthesia
  • Previous c-spine disc or had surgery
  • Teeth are severely shaken or poor
  • Moderate or severe obstructive/restrictive pulmonary disease accompanied by pulmonary function tests

研究组 & 干预措施

Control

No Intervention

Use in the shape of an endotracheal tube.

Group "O"

Experimental

Just before the induction of medicine is injected, the assistant makes endotracheal tube into "O" shape.

干预措施: group "O" (Other)

结局指标

主要结局

First intubation success rate for each between two group

时间窗: Immediately after intubation

First laryngoscope tries was success using detection of end tidal CO2

次要结局

  • Number of attempts(From the first tracheal intubation failure to the next successful tracheal intubation)
  • Measured vital sign(immediately before intubation and within 5 minites after intubation)
  • First intubation time(within 60 seconds)

研究者

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

Yu-Kyung Bae

clinical professor

Seoul National University Hospital

研究点 (1)

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