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临床试验/NCT07421440
NCT07421440已完成不适用

Outcome of Flexible Fiber Optic Bronchoscopy Usage in Children With Resistant Pneumonia in Pediatric Intensive Care Units (PICU )

Mansour Gomaa Mohammed Saleh1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Diagnostic yield of flexible fiberoptic bronchoscopy (FFB) in resistant pneumonia

研究概览

简要总结

Pneumonia remains a leading cause of morbidity and mortality among critically ill children admitted to Pediatric Intensive Care Units (PICUs). A proportion of patients fail to demonstrate clinical or radiological improvement despite receiving at least five days of appropriate broad-spectrum antibiotic therapy, a condition commonly referred to as resistant or non-resolving pneumonia. These patients often require further diagnostic evaluation to identify persistent infection, resistant microorganisms, airway abnormalities, or alternative diagnoses.

Flexible fiberoptic bronchoscopy (FFB) with bronchoalveolar lavage (BAL) is an important diagnostic procedure that permits direct visualization of the tracheobronchial tree and collection of lower respiratory tract specimens for microbiological analysis. The findings obtained through FFB may identify the underlying etiology of persistent pulmonary disease and guide subsequent therapeutic decisions.

This observational study aims to evaluate the diagnostic yield, clinical utility, safety, and impact of flexible fiberoptic bronchoscopy with bronchoalveolar lavage in children with resistant pneumonia admitted to the Pediatric Intensive Care Unit at Abu El-Reesh Children's Hospital, Cairo University. Eligible patients are children who demonstrate persistent clinical and radiological evidence of pneumonia despite receiving at least five days of appropriate first-line broad-spectrum antibiotic therapy.

Clinical characteristics, bronchoscopic findings, microbiological results, bronchoalveolar lavage cultures, molecular diagnostic results, treatment modifications, procedure-related complications, and clinical outcomes will be analyzed. The findings of this study are expected to provide evidence regarding the role of flexible bronchoscopy in the diagnostic evaluation and management of resistant pneumonia in critically ill pediatric patients.

详细描述

Lower respiratory tract infections remain a leading cause of morbidity and mortality among critically ill children admitted to Pediatric Intensive Care Units (PICUs). Despite appropriate empirical antimicrobial therapy, some patients continue to demonstrate persistent clinical and radiological evidence of pneumonia after at least five days of broad-spectrum antibiotic treatment. These patients are considered to have resistant or non-resolving pneumonia and often require additional diagnostic evaluation to identify persistent infection, resistant microorganisms, airway abnormalities, or alternative diagnoses.

Flexible fiberoptic bronchoscopy (FFB) with bronchoalveolar lavage (BAL) permits direct visualization of the tracheobronchial tree and collection of lower respiratory tract specimens for microbiological analysis. In addition to identifying airway abnormalities such as mucus plugging, tracheobronchitis, foreign body aspiration, airway malacia, or extrinsic airway compression, BAL specimens can be analyzed by conventional culture and molecular diagnostic methods to facilitate targeted antimicrobial therapy.

This prospective observational study was conducted in the Pediatric Intensive Care Unit of Abu El-Reesh Children's Hospital, Faculty of Medicine, Cairo University. Children aged 3 months to 14 years with resistant pneumonia who failed to improve clinically or radiologically after at least five days of first-line broad-spectrum antibiotic therapy and underwent clinically indicated flexible fiberoptic bronchoscopy with BAL were enrolled.

Clinical characteristics, laboratory investigations, inflammatory biomarkers, radiological findings, bronchoscopic findings, BAL microbiological results, antimicrobial susceptibility patterns, molecular diagnostic results, treatment modifications, procedure-related complications, and clinical outcomes were recorded and analyzed. The study evaluated the diagnostic yield and clinical utility of FFB with BAL, compared different microbiological diagnostic methods, assessed the impact of bronchoscopy on patient management, and evaluated clinical outcomes including inflammatory marker response, duration of oxygen therapy, length of PICU stay, and survival to PICU discharge.

The findings of this study contribute to understanding the diagnostic performance, safety, and clinical impact of flexible fiberoptic bronchoscopy with bronchoalveolar lavage in the evaluation and management of resistant pneumonia in critically ill pediatric patients.

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
3 Months 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • - Children aged more than 3 months and less than 14 years.
  • Admitted to Pediatric Intensive Care Unit (PICU).
  • Severe pneumonia defined as cough or difficulty breathing with at least one of the following:
  • Oxygen saturation < 90% on pulse oximetry
  • Severe respiratory distress
  • General danger signs (inability to drink, lethargy, convulsions)
  • No clinical or radiological improvement after at least five days of first-line broad-spectrum antibiotic therapy.
  • Informed consent obtained from parent or legal guardian.

排除标准

  • Age less than 3 months or more than 14 years.
  • Absolute contraindication to flexible bronchoscopy (severe refractory hypoxemia, hemodynamic instability, uncorrected bleeding disorder).
  • refusal of informed consent by parents or legal guardian

研究组 & 干预措施

Children with resistant pneumonia undergoing flexible fiberoptic bronchoscopy

Children admitted to the Pediatric Intensive Care Unit (PICU) with resistant pneumonia who showed no clinical or radiological improvement after at least 5 days of broad-spectrum antibiotic therapy and underwent flexible fiberoptic bronchoscopy with bronchoalveolar lavage as part of their diagnostic evaluation.

干预措施: Flexible fiberoptic bronchoscopy with bronchoalveolar lavage (BAL) (Procedure)

结局指标

主要结局

Diagnostic yield of flexible fiberoptic bronchoscopy (FFB) in resistant pneumonia

时间窗: During bronchoscopy and within 72 hours after bronchoscopy where FFB findings were obtained during the procedure and inflammatory markers/chest imaging were reassessed within 72 hours after FFB, with patients followed clinically until PICU discharge

Proportion of patients in whom flexible fiberoptic bronchoscopy with bronchoalveolar lavage identifies a specific etiological pathogen (bacterial, viral, or fungal) responsible for resistant pneumonia

Diagnostic yield of flexible fiberoptic bronchoscopy (FFB) in resistant pneumonia

时间窗: Within 7 days after bronchoscopy procedure

Proportion of patients in whom flexible fiberoptic bronchoscopy with bronchoalveolar lavage identifies a specific etiological pathogen (bacterial, viral, or fungal) responsible for resistant pneumonia

次要结局

  • Clinical improvement after flexible fiberoptic bronchoscopy(72 hours after bronchoscopy)
  • Microbiological diagnostic performance of bronchoalveolar lavage(Within 7 days after bronchoscopy)
  • Clinical outcomes following bronchoscopy(From bronchoscopy until PICU discharge)
  • Prevalence of resistant pneumonia in PICU(Within 7 days after bronchoscopy procedure)

研究者

发起方
Mansour Gomaa Mohammed Saleh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mansour Gomaa Mohammed Saleh

assistant lecturer of pediatrics

Cairo University

研究点 (1)

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