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临床试验/NCT04467307
NCT04467307Unknown不适用

Comparison of Symptoms and Findings and Short-term Results After Bronchoscopy in Patients With and Without the Foreign Body in Children Under 5 Years Old Who Underwent Bronchoscopy With Suspicion of Foreign Body Aspiration. A Prospective Study.

Kahramanmaras Sutcu Imam University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Foreign body aspiration

研究概览

简要总结

To compare patients under 5 years of age with foreign body aspiration and without foreign body aspiration with radiological and blood gas results.

详细描述

Foreign body aspiration in children is a serious cause of mortality and morbidity. It is a preventable and treatable disease. Difficulties in diagnosis arise in non-radiopaque foreign body aspirations. Recently, when there is a suspicious history, bronchoscopy is recommended. Bronchoscopy is used to both diagnose and treat foreign body aspiration. Bronchoscopy seems to continue to be performed in suspicious cases until a method to establish a definitive diagnosis of foreign body aspirations before the operation is invented. In our study, to compare patients under 5 years of age with foreign body aspiration and without foreign body aspiration with radiological and blood gas results.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •Suspected foreign body aspiration

排除标准

  • •infection, trauma

研究组 & 干预措施

Foreign body aspiration.

Active Comparator

Patients undergoing bronchoscopy with suspicion of foreign body aspiration. There is a foreign body in the bronchoscopy performed on these patients and it is the treated group.

干预措施: Rigit bronchoscopy (Device)

Group with no foreign body aspiration

Active Comparator

Patients undergoing bronchoscopy with suspicion of foreign body aspiration, but there is no foreign body in bronchoscopy.

干预措施: Rigit bronchoscopy (Device)

结局指标

主要结局

Foreign body aspiration

时间窗: 1 week

The presence of a foreign body in the airway by bronchoscopy, radiological findings, blood gas

次要结局

未报告次要终点

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet Gökhan Güler

Department of pediatric surgery

Kahramanmaras Sutcu Imam University

研究点 (1)

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