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临床试验/NCT03462732
NCT03462732已完成不适用

Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery , Prospective Randomized Clinical Trial

Ain Shams University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年2月10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
80
试验地点
2
主要终点
incidence and severity of Epistaxis

研究概览

简要总结

The value of this study is to compare between stented endotracheal tube with nelaton catheter and non stented tube as regard nasotracheal related complications as epistaxis and nasal cavity injury.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients scheduled for dental surgery under general anesthesia age 3-9 years
  • physical status American society of Anesthesiologist(ASA) I orII

排除标准

  • History of recurrent epistaxis
  • Coagulopathy
  • Previous nasal surgery
  • History of nasal trauma
  • Severe renal , hepatic or cardiovascular disease
  • History of drug allergy to the drugs used in the study

结局指标

主要结局

incidence and severity of Epistaxis

时间窗: immediately after nasotracheal intubation

An independent anesthesiologist who did not observe the tube insertion will assess the incidence and severity of epistaxis using a laryngoscope immediately after tube passage through the nasal cavity , four grades to evaluate epistaxis 1- no epistaxis 2- mild epistaxis ,blood apparent on the surface of the tube 3-moderate epistaxis pooling of blood on the posterior pharyngeal wall 4- severe epistaxis , large amount of blood in the pharynx impeding nasotracheal intubation and necessitating urgent orotracheal intubation.

次要结局

  • Histopathology of the endotracheal tube contents after extubation(immediately after extubation)

研究者

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

Amin Mohammed Alansary Amin Ahmed Helwa

Assistant Professor

Ain Shams University

研究点 (2)

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