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临床试验/NCT02376101
NCT02376101已完成不适用

Minimal Occlusive Pressure With Cuffed ETT: the Effect of Size on Intracuff Pressure

Senthil G. Krishna0 个研究点目标入组 100 人开始时间: 2014年10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
发起方
入组人数
100
主要终点
Intracuff pressure

研究概览

简要总结

The purpose of this current study is to evaluate whether the size of the endotracheal tube (ETT) that is used impacts the intracuff pressure that occurs when the airway is sealed. If there is excessive pressure in the cuff of a smaller ETT when it is inflated, there may be inherent risks associated with the use of a cuffed endotracheal tube that is less than the appropriate size. The investigators believe that the size of the tube chosen has an impact on the characteristics of the inflated cuff and hence the intracuff pressure and the sealing pressure are variable.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Patients requiring intubation with an ETT for a surgical procedure.
  • •Children ages 4 to 8 years old.
  • •Surgical procedure lasting less than 60 minutes.

排除标准

  • •Patients undergoing a surgical procedure that is anticipated to last longer than 60 minutes.
  • •Patients that are known or anticipated to have a difficult airway.

研究组 & 干预措施

Standard ETT size

Active Comparator

Their tracheas will be intubated with an appropriately sized ETT using the standard formula. The cuff will be inflated to achieve a seal by the air-leak test when holding CPAP of 20 cmH2O and the intracuff pressure will be measured using a manometer.

干预措施: Surgery less than 60 minutes (Procedure)

ETT one size smaller

Experimental

Their tracheas will be intubated with an ETT that is one size smaller (instead of a 5.0 ETT, we would use a 4.0 ETT). The cuff will be inflated to achieve a seal by the air-leak test when holding CPAP of 20 cmH2O and the intracuff pressure will be measured using a manometer.

干预措施: Surgery less than 60 minutes (Procedure)

结局指标

主要结局

Intracuff pressure

时间窗: intraoperative

Our goal is to measure the intracuff pressure that is achieved when the airway is sealed with an ETT based on the formula (ETT=(age/4)+3) and compare it to the intracuff pressure when the airway is sealed with an ETT that is 1 size smaller (4.0 mm instead of 5.0 mm).

次要结局

未报告次要终点

研究者

发起方
Senthil G. Krishna
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Senthil G. Krishna

Assistant Professor

Nationwide Children's Hospital

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