Fiberoptic Bronchoscopy in Severe Ventilator-associated Pneumonia

NCT07149909 | Completed

• 1 other identifier: MD: 8-11-2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-Associated Pneumonia; Severe Pneumonia; Critical Illness

Keywords

Fiberoptic bronchoscopy; Bronchoalveolar lavage (BAL); Mechanical ventilation; Intensive care unit (ICU); Respiratory infection; Secretion clearance; Culture-directed antibiotics; Severe VAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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).

Study Arms (2)

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.

Other: Other (Conventional Therapy)

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.

Procedure: Fiberoptic Bronchoscopy

Interventions

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.

Control Group

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.

Fiberoptic Bronchoscopy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Benha, 13511, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia; Critical Illness; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label trial; neither participants, care providers, nor investigators were blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Critical Care Medicine

Model Details: Participants were randomly assigned to receive either standard therapy alone or standard therapy plus fiberoptic bronchoscopy.

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: December 15, 2023
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

EG (1)