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Fiberoptic Bronchoscopy in Severe Ventilator-associated Pneumonia

B

Benha University

Status

Completed

Conditions

Ventilator-Associated Pneumonia
Critical Illness
Severe Pneumonia

Treatments

Other: Other (Conventional Therapy)
Procedure: Fiberoptic Bronchoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT07149909
MD: 8-11-2023

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Control Group
Active Comparator group
Description:
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.
Treatment:
Other: Other (Conventional Therapy)
Fiberoptic Bronchoscopy Group
Experimental group
Description:
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.
Treatment:
Procedure: Fiberoptic Bronchoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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