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临床试验/NCT02768831
NCT02768831已完成不适用

Minimal Occlusive Pressure With Cuffed ETTs: A Comparison of Two Different Techniques to Ensure a Tracheal Seal

Nationwide Children's Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Intracuff pressure

研究概览

简要总结

In the past 5 years cuffed endotracheal tubes (ETT) have become the standard of care in pediatrics. However, hyperinflation of the cuff can compromise the tracheal mucosal perfusion while an inadequate seal may impact ventilation and potentially increase the risk of aspiration. Hence, the goal after placement of a cuffed ETT is to create a safe and effective tracheal seal. The two ways to measure that are to hold CPAP while listening for an audible leak and measuring the difference between the inspired and expired tidal volumes (TV). This is a prospective study to compare these two methods used to create a tracheal seal and measure the intracuff pressure after a satisfactory tracheal seal is established.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Children who are scheduled to undergo GA with a cuffed ETT in place.

排除标准

  • Any children with pre-existing tracheal/bronchial anomalies, patients with Down syndrome, patients with C-spine issues.

结局指标

主要结局

Intracuff pressure

时间窗: Immediately following intubation

Difference in intracuff pressure measured after inflation with CPAP and inflation with TV.

次要结局

未报告次要终点

研究者

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

Senthil G. Krishna

Assistant Professor

Nationwide Children's Hospital

研究点 (2)

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