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临床试验/NCT03368911
NCT03368911已完成不适用

The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness

Chonnam National University Hospital4 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年12月1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
4
主要终点
sore throat

研究概览

简要总结

The purpose of this study is an evaluation of the effect of the reinforced endotracheal tube on post-operative hoarseness and sore throat undergoing thyroidectomy

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
Single (Outcomes Assessor)

盲法说明

Primary outcome is assessed by other investigator who do not know which endotrachdeal tube is used.

入排标准

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

入选标准

  • American Society of Anesthesiologist physical status 1-3
  • Patients undergoing thyroidectomy under general anesthesia
  • Tumor size < 2cm
  • Patient who do not have any problem in the vocal cord

排除标准

  • Patient who is expected difficult intubation (Mallampati class 3 or more)
  • Patient who has respiratory disorder
  • Previous hoarseness and sore throat history
  • Obesity (BMI > 30 kg/m2)
  • Recurrent laryngeal injury during operation
  • Operation history of oral and laryngeal surgery

研究组 & 干预措施

Reinforced tube group

Experimental

use an reinforced endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy

干预措施: Oral/Nasal Endotracheal Tube, Reinforced (Covidien) (Device)

Conventional tube group

Active Comparator

use an conventional endotracheal tube for endotracheal intubation during general anesthesia undergoing thyroidectomy

干预措施: TaperGuard oral tracheal tube (Covidien) (Device)

结局指标

主要结局

sore throat

时间窗: assess after 48 hours after operation

compare the incidence and degree of the sore throat after thyroidectomy

hoarseness

时间窗: assess after 48 hours after operation

compare the incidence and degree of the hoarseness after thyroidectomy

次要结局

未报告次要终点

研究者

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

Seongtae Jeong

Associate Professor

Chonnam National University Hospital

研究点 (4)

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