Critical Illness, Severe Pneumonia, Ventilator-Associated Pneumonia
Conditions
Keywords
Fiberoptic bronchoscopy, Bronchoalveolar lavage (BAL), Mechanical ventilation, Intensive care unit (ICU), Respiratory infection, Secretion clearance, Culture-directed antibiotics, Severe VAP
Brief summary
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.
Interventions
OTHEROther (Conventional Therapy)
Participants received standard therapy including culture-guided antibiotics, tracheal lavage, and aspiration. Sputum samples were collected from the lower trachea for culture and sensitivity testing to guide antibiotic selection.
PROCEDUREFiberoptic Bronchoscopy
Participants underwent fiberoptic bronchoscopy through the endotracheal tube for secretion clearance, sample collection, and alveolar lavage once daily for one week. Sterile sodium chloride solution with ambroxol hydrochloride was instilled, and antibiotics were administered immediately after lavage. Samples were cultured to guide antibiotic therapy.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This was an open-label trial; neither participants, care providers, nor investigators were blinded to group allocation.
Intervention model description
Participants were randomly assigned to receive either standard therapy alone or standard therapy plus fiberoptic bronchoscopy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Effective Treatment Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Time | Up to 28 days from diagnosis. | Duration from diagnosis of ventilator-associated pneumonia (VAP) until Modified Clinical Pulmonary Infection Score (CPIS) decreased to below 6. |
| Length of intensive care unit (ICU) stay | From intensive care unit (ICU) admission until discharge (maximum 28 days). | Total number of days spent in the intensive care unit during the hospital admission. |
Countries
Egypt
Outcome results
None listed