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NCT Number: NCT07149909

Fiberoptic Bronchoscopy in Severe Ventilator-associated Pneumonia

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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Key information

Conditions

Ventilator-associated Pneumonia Critical Illness Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Severe Pneumonia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Benha, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Overall Effective Treatment Rate

    Time frame: 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 outcomes

  1. Recovery Time

    Time frame: 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.

  2. Length of intensive care unit (ICU) stay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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