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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | 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. |
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| Fiberoptic Bronchoscopy Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other (Conventional Therapy) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Effective Treatment Rate | 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. | Postoperatively (within 28 days of VAP diagnosis). |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery Time | Duration from diagnosis of ventilator-associated pneumonia (VAP) until Modified Clinical Pulmonary Infection Score (CPIS) decreased to below 6. | Up to 28 days from diagnosis. |
| Length of intensive care unit (ICU) stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University | Banhā | Benha | 13511 | Egypt |
Individual participant data (de-identified) that underlie the results reported in this trial will be made available to qualified researchers upon reasonable request for the purpose of meta-analyses and further research on ventilator-associated pneumonia management.
De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the main study results and for up to 5 years thereafter.
Researchers who provide a methodologically sound proposal will be granted access after review and approval by the principal investigator and the Research Ethics Committee of Benha Faculty of Medicine. Data will be shared through secure data transfer agreements to ensure confidentiality.
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D011014 | Pneumonia |
| D016638 | Critical Illness |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D008171 | Lung Diseases |
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Participants were randomly assigned to receive either standard therapy alone or standard therapy plus fiberoptic bronchoscopy.
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This was an open-label trial; neither participants, care providers, nor investigators were blinded to group allocation.
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| Fiberoptic Bronchoscopy | Procedure | 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. |
|
Total number of days spent in the intensive care unit during the hospital admission.
| From intensive care unit (ICU) admission until discharge (maximum 28 days). |
| D012140 |
| Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |