跳至主要内容
临床试验/NCT02666300
NCT02666300Unknown不适用

To Compare the Incidence of Postoperative Sore Throat Between a TaperGuardEndotracheal Tube(ETT)and a Cylindrical-shaped ETT Under Highcuffpressure:A Randomized,Double-blindTrial.

The Second Affiliated Hospital of Dalian Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
The incidence and severity of Participants with Cylindrical ETT at 0,1,,6,12,24 hours post-operative

研究概览

简要总结

Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory complication related to endotracheal intubation .Whether the new type of ETT(TaperGuard ETT) to decrease or to increase the complications of general anesthesia compared with Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different incidence of complications following general anesthesia between TaperGuard ETT and Cylindrical-shaped ETT under high endotracheal tube cuff pressure.

详细描述

BACKGROUND:Postoperative Sore Throat (POST) is supposed to be the most frequently occurred respiratory complication related to endotracheal intubation .Endotracheal tube size ,airway manipulation ,patients position et al. have been recognized as the factors affecting Postoperative Sore Throat .Controversy in respect of the relationship between the cuff design and POST is still existed. Whether the new type of ETT (TaperGuard ETT) to decrease or to increase the complications of general anesthesia compared with Cylindrical-shaped ETT is still unknown .In this study ,we will compare the different incidence of complications following general anesthesia between TaperGuard ETT and Cylindrical-shaped ETT under high endotracheal tube cuff pressure.

METHODS:Patients undergoing elective non-throat and non-neck surgery were randomly allocated to receive either a TaperGuard ETT(group T) or Cylindrical-shaped ETT ( Group C).Patients received general anesthesia with different endotracheal tubes .Recoil of inflation syringe plunger was used to inflate the cuff. In the study , the cuff pressures of the endotracheal tube were recorded by a calibrated cuff manometer at two time: when the intubation was complited and before endotracheal tube was removed. The incidence and severity of Postoperative Sore Throat(POST),hoarseness, cough were collected by a single investigator blinded to the experiment at 0, 1,6, 12, and 24 hours post-operation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • General anesthesia surgery
  • aged 18 to 75 years
  • ASA classⅠ or Ⅱ
  • undergoing elective non-throat and non-neck surgery under generalanesthesia
  • intubation timemore than two hours
  • BMI≤30 kg/m2

排除标准

  • Patients with ahistory of preoperative sore throat
  • known airway disease and difficult intubation
  • more than one attempt at intubation
  • Mallampati grade 3 to 4
  • Cormack-Lehane grade3 to 4
  • BMI >35 Kg/m2
  • Those have an operation with the lateral flank or prone position

结局指标

主要结局

The incidence and severity of Participants with Cylindrical ETT at 0,1,,6,12,24 hours post-operative

时间窗: 0,1,,6,12,24 hours post-operative

The incidence and severity of Participants with TaperGuard ETT at 0,1,,6,12,24 hours post-operative

时间窗: 0,1,,6,12,24 hours post-operative

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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