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临床试验/NCT01626365
NCT01626365已完成不适用

The Effect of Double-lumen Tube Thermosoftening Before Intubation to Reduce Hoarseness and Sore Throat

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2012年5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
154
试验地点
1
主要终点
Postoperative hoarseness

研究概览

简要总结

The purpose of this study is to investigate the effect of double-lumen tube thermosoftening before intubation to reduce postoperative hoarseness and sore throat.

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
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

排除标准

  • •Preoperative hoarseness or sore throat
  • •History of upper airway diseases
  • •Anticipated difficult airway
  • •Anesthesia time longer than 6 hours

研究组 & 干预措施

non-thermosoftening

Active Comparator

Double-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation.

干预措施: non-thermosoftening (Procedure)

thermosoftening

Experimental

Double-lumen tube is put into a bottle of warm normal saline (40°C) before intubation.

干预措施: thermosoftening (Procedure)

结局指标

主要结局

Postoperative hoarseness

时间窗: up to 3 days after surgery

postoperative sore throat

时间窗: up to 3 days after surgery

次要结局

  • Vocal cord injuries(up to 1 day after surgery)

研究者

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

Jae-Hyon Bahk, MD, PhD

professor

Seoul National University Hospital

研究点 (1)

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