Ventilator-Associated Pneumonia
Conditions
Interventions
Sample size was estimated at 76 patients (38/38) that were randomized to one of the study groups: Group 1: BAL-Group and Group 2: Endotracheal Group.
Both BAL fluid (BALF) and EA samples were culture
Procedure/surgery
E05.927.100
Sponsors
Faculdade de Medicina da Universidade Federal de Minas Gerais
Faculdade de Medicina da Universidade Federal de Minas Gerais
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Result: BAL group: 25,0% Tracheal aspirate group: 37,8% p= 0,353 | — |
Secondary
| Measure | Time frame |
|---|---|
| Similarity of the following variables between the study groups: 1. Length of ICU stay (days)(p = 0,797): - BAL Group: 14 , 28:16 (44,5%) - Tracheal Aspirate Group: 14 , 28: 14 (37,9%) 2. Adverse events due to sampling techniques: (p = NS): - BAL Group: Dessaturation (120): 7 (19,4%) - Tracheal Aspirate Group: Dessaturation:(<90%): 3 (8,1%) Sinus tachicardia: 1 (2,7%) Bradicardia: 1 (2,7%) 3. Appropriateness of antibiotic therapy: - BAL Group: 28 (77,8%) - Tracheal Aspirate Group: 30 (83,3%) p = 0,551 4. Rate of modifications in the antibiotic therapy: - BAL Group: 7/8(87,5%) - Tracheal Aspirate Group: 6/6(100%) p = 1,0 5. Occurrence of secondary sepsis: - BAL Group: 20/21 (95,2%) - Tracheal Aspirate Group: 20/21 (95,2%) p = 1,0 6. Occurrence of severe sepsis - BAL Group: 5/25 (20,0%) - Tracheal Aspirate Group: 2/19 (10,5%) p = 0,680 7. Occurrence of septic shock: - BAL Group:10/35(28,6%) - Tracheal Aspirate Group: 15/33(45,5%) p = 0,149 8. VAP recurrence - BAL Group: 0/36 (0%) - Tracheal Aspirate Group:2/36 (5,6%) p = 0,151 9. Need for additional diagnostic procedures: - Second tracheal aspirate: BAL Group: (n1=8? n2=11) 0/8 (0%) Tracheal Aspirate Group: 4/11 (36,4% p = 0,085 - Second BAL: BAL Group: 0/8 (0%) Tracheal Aspirate Group: 0/11 (0%) p = 1,0 - Haemoculture: BAL Group: 2/8 (25,0%) Tracheal Aspirate Group:2/11 (18,2%) p = 1,0 All the outcomes were verified by the investigators through daily visits to the patients in the ward until their discharge or their death, with an expected variation of 10% in the rates between the groups. | — |
Countries
Brazil
Contacts
Public ContactManoel;Ricardo Rocha;Corrêa
Programa de Pós-Graduação: Infectologia e Medicina Tropical - Faculdade de Medicina da Universidade Federal de Minas Gerais;Programa de Pós-Graduação: Infectologia e Medicina Tropical - Faculdade de Medicina da Universidade Federal de Minas Gerais
Outcome results
None listed