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临床试验/NCT01095861
NCT01095861已完成不适用

Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube: A Randomized Controlled Trial

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年7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
200
试验地点
2
主要终点
Sore throat

研究概览

简要总结

Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tubes (ETT).

详细描述

The post-operative complication of a sore throat after endotracheal intubation is unfortunately common, with estimates ranging from 15-50%. Most estimates are in the order of 35-45%.(McHardy 1999, Higgins 2002) There is evidence that many patients do not report sore throat and/or vocal changes unless directly asked because surgical pain is more prominent and many patients may be unaware that intubation completed as part of the general anesthetic. (Harding 1987)

The Parker FlexTip® endotracheal tube (ETT) is formulated with a softer plastic at the distal tip as well as a laterally curved profile to reduce trauma during ETT advancement. (Makino 2003) This ETT has been shown to be faster during fibreoptic intubation, but complication of sore throat was not examined. (Kristensen 2003)

Our previous study (Jones 2007) demonstrated that modification of anesthetic techniques could reduce the incidence of post-operative sore throat in patients undergoing naso-tracheal intubation. We will now study the Parker Flex-Tip ETT to see if its use can also reduce the incidence of sore throat in patients undergoing oro-tracheal intubation.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any adult patient scheduled for elective surgery.
  • ETT is indicated for the procedure in the opinion of the attending anesthesiologist.

排除标准

  • Any patients with known or probable difficult airways.
  • Any patient requiring rapid sequence induction.

结局指标

主要结局

Sore throat

时间窗: 48-72 hours

Patients fill in a questionaire 48-72 hours after Surgery by a blinded data assessor. They are asked if they had a sore throat after their surgery. If so, they are asked to grade the sore throat as mild, moderate, or severe, when it was at its worst. Note: There is only one questionaire for both outcomes.

次要结局

  • Vocal changes(48-72 hours)

研究者

申办方类型
Other

研究点 (2)

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