Comparison of Bronchoalveolar Lavage and Tracheal Aspirate in the diagnosis and therapy of ICU patients with Ventilator-Associated Pneumonia

Phase 4

• Conditions: Ventilator-Associated Pneumonia; Nosocomial Infections; C01.539.248.500; C01.539.248; E02.041.625

• Registration Number: RBR-86dcdx
• Lead Sponsor: Faculdade de Medicina da Universidade Federal de Minas Gerais

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

The patients under mechanical ventilation for at least 48 h who presented with new or progressive pulmonary infiltrates on X-rays plus at least two criteria among fever > 38°C, purulent tracheal secretions, and leukocytos greater than 10,000 cells/mm3 or leukopenia of 4,000 cells/mm3, were screened for enrollment.These patients were randomized to undergo BAL (BAL group - 1) or EA (EA group - 2).
Both BAL fluid (BALF) and EA samples were quantitaively cultured. The patients whose cultures were positive with more than 10.000 CFU/mL in BALF cultures and with more than 100.000 CFU/mL in quantitatively endotracheal aspirate cultures (QEACs)— were included in the
study.

Exclusion Criteria

The exclusion criteria were a diagnosis of AIDS and inappropriate
respiratory samples (> 10 squamous cells in the lower field magnification in EA
smears or > 1% bronchial cells in BALF smears). cases with BAL fluid with more than 1% of bronchial cells.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Similarity of 28-day mortality rate between the study group in the hospital until their discharge or their death, which one that ocurred first, from an estimated rate of 40% with a variation of 10%. The 28-day mortality rate was calculated through the number of deaths in this period (since the inclusion in the study) over the number of patients observed/included.<br><br>Result:<br>BAL group: 25,0%<br>Tracheal aspirate group: 37,8% <br>p= 0,353