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临床试验/NCT07150689
NCT07150689尚未招募不适用

Assessment of Outcome of Bronchoscopy in Pediatric Patients With Suspected Foreign Body Aspiration Attending at Assiut University Children Hospital

Assiut University0 个研究点目标入组 75 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
主要终点
Rate of Successful Foreign Body Removal

研究概览

简要总结

Outcome of Bronchoscopy in Pediatric patient with foreign body aspiration

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

Masking Description

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •children less than 18 years with suspected foreign body aspiration

排除标准

  • •children with congenital airway anomalies other than foreign body aspiration

研究组 & 干预措施

Rigid Bronchoscopy

Active Comparator

Standard of care in most pediatric centers; performed under general anesthesia to visualize and remove FB. Gold standard for both diagnosis and treatment

干预措施: Rigid bronchoscopy (Procedure)

Flexible Bronchoscop

Experimental

Flexible scope used for diagnosis and sometimes removal (especially in distal airways or when FB is small). Evaluate if less invasive flexible bronchoscopy can be effective.

干预措施: Flexible scope (Procedure)

Combined Approach

Experimental

Initial flexible bronchoscopy for diagnosis and airway inspection, followed by rigid bronchoscopy for removal if needed. Compare efficiency and safety of combined method.

干预措施: Combined Flexible-Rigid Bronchoscopy (Procedure)

Imaging-Guided Approach

Experimental

High-resolution CT or virtual bronchoscopy first; bronchoscopy only if imaging suggests FB. Assess if imaging can reduce unnecessary bronchoscopies.

干预措施: Imaging-Guided Bronchoscopy (Procedure)

结局指标

主要结局

Rate of Successful Foreign Body Removal

时间窗: During bronchoscopy procedure (intra-operative, within 24 hours of intervention).

The proportion of patients in whom the foreign body is completely removed during the initial bronchoscopy procedure, as confirmed by direct visualization and/or post-procedure imaging.

次要结局

  • Incidence of procedure-related complications (within 24 hours).(Intra-procedure and up to 24 hours post-procedure.)

研究者

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

Marsail Refat Kadry

Resident

Assiut University

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