Fiberoptic Bronchoscopy in Severe Ventilator-associated Pneumonia

The Clinical Effect of Fiberoptic Bronchoscopy in Management of Adult Patients With Severe Ventilator-associated Pneumonia; a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Ventilator-Associated Pneumonia; Severe Pneumonia
• Intervention / Treatment: Other: Other (Conventional Therapy); Procedure: Fiberoptic Bronchoscopy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Benha
    • Banhā, Benha, Egypt, 13511
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Other (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.
Experimental: 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.	Procedure: Fiberoptic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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	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).

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: August 24, 2025
• First Submitted That Met QC Criteria: August 24, 2025
• First Posted (Actual): September 2, 2025

Study Record Updates

• Last Update Posted (Actual): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 24, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Respiratory infection; Fiberoptic bronchoscopy; Secretion clearance; Intensive care unit (ICU); Bronchoalveolar lavage (BAL); Culture-directed antibiotics; Severe VAP
• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Pathologic Processes; Disease Attributes; Infections; Respiratory Tract Diseases; Lung Diseases; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Critical Illness; Pneumonia; Respiratory Tract Infections; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: MD: 8-11-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No