The Clinical Effect of Fiberoptic Bronchoscopy in Management of Adult Patients With Severe Ventilator-associated Pneumonia; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall Effective Treatment Rate
研究概览
简要总结
This randomized controlled trial evaluated the clinical effect of fiberoptic bronchoscopy in the management of adult patients with severe ventilator-associated pneumonia (VAP). A total of 100 patients admitted to the Critical Care Department at Benha University Hospitals were enrolled and randomly assigned in equal numbers to two groups. The control group received standard therapy, including culture-guided antibiotics, lavage, and aspiration. The intervention group received the same treatment plus fiberoptic bronchoscopy for secretion clearance, lavage, and culture-directed antibiotic therapy.
The primary outcome was the overall effective treatment rate, defined as the proportion of patients with significant or partial clinical improvement. Secondary outcomes included recovery time, length of intensive care unit stay, respiratory mechanics, inflammatory markers (C-reactive protein and procalcitonin), recurrence of pulmonary infection, and 28-day mortality.
The study demonstrated whether the addition of fiberoptic bronchoscopy to conventional treatment improved clinical outcomes in patients with severe ventilator-associated pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This was an open-label trial; neither participants, care providers, nor investigators were blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years
- •Patients of both sexes
- •Patients requiring mechanical ventilation
- •Development of pneumonia ≥ 48 hours after endotracheal intubation or ≥ 48 hours after extubation
- •Diagnosis of severe ventilator-associated pneumonia defined by a Modified Clinical Pulmonary Infection Score (CPIS) > 6
排除标准
- •Refusal to participate
- •Presence of lung shadows prior to mechanical ventilation
- •Severe bleeding disorders or immune system diseases
- •Severe hemodynamic instability
- •Recent myocardial infarction or unstable arrhythmia
- •Tracheal stenosis or upper airway mass
研究组 & 干预措施
Control Group
Participants received standard therapy for severe ventilator-associated pneumonia, which included culture-guided antibiotics, routine drug therapy, tracheal lavage, and aspiration. Sputum samples were collected for bacterial culture and sensitivity testing to guide antibiotic selection.
干预措施: Other (Conventional Therapy) (Other)
Fiberoptic Bronchoscopy Group
Participants received the same standard therapy as the control group plus fiberoptic bronchoscopy. The bronchoscope was inserted via the endotracheal tube to clear secretions, obtain samples for culture, and perform bronchoscopic alveolar lavage. Lavage was performed once daily for one week using sterile sodium chloride solution with ambroxol hydrochloride, followed by antibiotic administration. Cultures were used to guide therapy.
干预措施: Fiberoptic Bronchoscopy (Procedure)
结局指标
主要结局
Overall Effective Treatment Rate
时间窗: Postoperatively (within 28 days of VAP diagnosis).
Proportion of patients achieving significant or partial clinical improvement based on resolution of symptoms, normalization of temperature and laboratory markers, negative sputum cultures, and radiologic improvement.
次要结局
- Recovery Time(Up to 28 days from diagnosis.)
- Length of intensive care unit (ICU) stay(From intensive care unit (ICU) admission until discharge (maximum 28 days).)
研究者
Gehad Mohamed Mohsen Mahmoud
Assistant Lecturer of Critical Care Medicine
Benha University