跳至主要内容
临床试验/NCT02851641
NCT02851641已完成不适用

Risk and Importance of Peroperative Nasal Hemorrhage in the Treatment of Lacrimal Duct Obstruction in Young Children

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2015年9月2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
108
试验地点
1
主要终点
Nasal hemorrhage

研究概览

简要总结

The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a "pushed" probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO).

In the investigator's experience, this risk seemed to minus using a pushed probe rather than the classical pulled-type probes.

A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the use of an orolaryngeal mask. A forthcoming study will evaluate the results of this anesthetic change.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • < 6 years of age
  • Unilateral lacrimal duct obstruction with programmed surgery
  • Surgery scheduled wih a "pushed" mono-canaliculonasal intubation
  • No opposition of parents for he participation of their child

排除标准

  • Coagulation disorder
  • Previous history of nasolacrimal intubation (homo or contra-lateral)
  • Non covered by health insurance

结局指标

主要结局

Nasal hemorrhage

时间窗: Through surgery completion, an average of 1 hour

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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