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临床试验/NCT02512770
NCT02512770已完成不适用

Esaphageal Balloon Dilatation in Children: Hemodynamic , Ventilatory Changes and Complications

Istanbul University0 个研究点目标入组 60 人开始时间: 2015年1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
60
主要终点
peak inspiratory pressure

研究概览

简要总结

The aim of this study compares hemodynamic and respiratory changes and complications in children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only control.

详细描述

Esophageal strictures in children may develop as a secondary to a surgically repaired esophageal atresia (anastomatic strictures) or as a result of chemical injury after caustic ingestion. Emerging strictures are dilated with balloon catheter at regular intervals.

The possibility of various complications depending on the level of the stenosis during the dilation of esophagus. During Esophageal dilation may be pressed into airways and/or vascular structure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • endoscopy for esaphageal dilatation and control
  • ASA I-III
  • 0-16 year old

排除标准

  • endoscopy for removing foreing body

结局指标

主要结局

peak inspiratory pressure

时间窗: at time of endoscopy(0-40minute)

次要结局

  • mean arterial pressure-mmHg(at time of endoscopy(0-40minute))
  • heart rate-per/min(at time of endoscopy(0-40minute))
  • pressure levels for target tidal volume(at time of endoscopy(0-40minute))
  • complications ( laryngospasm, bronchospasm, can not be ventilated, decreased Sp02)(at time of endoscopy and after the endoscopy within 2 hours)
  • Sp02(at time of endoscopy and after the endoscopy within 2 hours)

研究者

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

pinar kendigelen

M.D.(Anesthesiology Specialist)

Istanbul University

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