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临床试验/NCT03432403
NCT03432403已完成不适用

The Effect of Esophagogastroduodenoscopy Scope Insertion on the Intracuff Pressure of a New, Modified Laryngeal Mask Airway in Children

Jason Bryant1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Excessive intracuff pressure

研究概览

简要总结

The purpose of this current study is to compare changes of the intracuff pressure in the newly designed LMA with the older design LMA after insertion of an esophagogastroduodenoscopy (EGD) probe in pediatric patients and adolescents.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who weigh more than 30 kg
  • Patients undergoing an EGD
  • Patients getting an LMA

排除标准

  • Patients who weigh less than 30 kg
  • Use of an EGD probe with an OD greater than 14 mm
  • Decision not to use an LMA for the procedure
  • Tracheomalacia, bronchomalacia, or any other airway issues

结局指标

主要结局

Excessive intracuff pressure

时间窗: as long as the LMA is in place in the OR with usually a max amount of time of 45 minutes

Our primary goal is to compare the incidence of excessive intracuff pressure after EGD probe insertion between the newly designed LMA and the older version LMA. For this primary outcome, we will define excessive intracuff pressure as ≥40 cmH2O.

次要结局

未报告次要终点

研究者

发起方
Jason Bryant
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jason Bryant

Anesthesiologist

Nationwide Children's Hospital

研究点 (1)

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