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临床试验/NCT00953433
NCT00953433已完成不适用

Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
Postoperative hoarseness

研究概览

简要总结

This study is aimed at reducing the risk of hoarseness and damage to the vocal cords following general anaesthesia. Conventional endotracheal intubation with use of a stylet will be compared with the Endoflex tube. A conventional stylet enforced endotracheal tube is dirigible because of the stiffness gained by the addition of a stylet. In high risk rapid sequence intubation settings the enhanced dirigibility can be crucial, which is why most anaesthesiologists choose to add the stylet in these situations. A new endotracheal tube with a dynamic dirigible end called the Endoflex tube might prove to be a good alternative to the conventional stylet enforced endotracheal tube.

Study hypothesis: The Endoflex tube will reduce the risk of hoarseness after intubation when compared to the conventional stylet enforced endotracheal tube under optimal intubation conditions.

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
Triple (Participant, Investigator, 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

入选标准

  • Elective surgical patients who require an endotracheal tube during general anaesthesia.
  • Informed consent.
  • Legally competent.
  • Be able to understand Danish and be able to read the given information in Danish.

排除标准

  • Planned or former operation in or around the pharynx or the larynx.
  • Cancer, infection or sequelae in or around the pharynx or the larynx.
  • Use of a stomach tube before or during surgery.
  • Suspected difficult intubation.

结局指标

主要结局

Postoperative hoarseness

时间窗: 1 hr postoperatively

次要结局

  • Vocal cord sequelae(After 4 weeks)
  • Intubation conditions(During and after intubation - on average 5 minutes)
  • Intubation difficulty scale(During and after intubation - on average 5 minutes)
  • Voice Range Profile(After 4 weeks)
  • Multi Dimensional Voice Profile(After 4 weeks)
  • Voice Handicap Index(72 hr postoperatively)

研究者

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

Martin Kryspin Soerensen

MD

Rigshospitalet, Denmark

研究点 (2)

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