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Lack of resources.
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The study is designed to evaluate sensitivity, specificity and accuracy of non-bronchoscopic bronchoalveolar lavage and endotracheal aspirate in comparison with bronchoscopic bronchoalveolar lavage (gold standard), as methods for etiologic diagnosis of ventilator associated pneumonia and their impact in morbimortality.
Ventilator associated pneumonia is defined as one that occurs 48-72h after tracheal intubation, is classified into early and late and is responsible for a mortality of 24-50% to almost 70% in some studies.
The clinical suspicion of ventilator associated pneumonia is based on the finding of new or progressive pulmonary opacity associated with two or more variables such as: fever, leukocytosis or leukopenia, and purulent pulmonary secretions.
Some studies show that the etiologic diagnosis reduces spectrum of antimicrobials and bacterial resistance, reducing hospital stay and time of mechanical ventilation, as well as treatment costs. The collection of material for quantitative culture ensures greater specificity however there is no standard method.
The investigator's hypothesis is that collection of material to confirm the etiologic diagnosis of ventilator associated pneumonia, held by bronchoscopic bronchoalveolar lavage, define the etiology in a larger number of patients when compared to the endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage.
The primary goal is evaluate and compare the sensitivity and specificity of noninvasive methods (endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage) in comparison with invasive (bronchoscopic bronchoalveolar lavage) regarding the collection of material for etiologic diagnosis.
The secondary objectives are determine the prevalence of ventilator associated pneumonia and antimicrobial susceptibility patterns of bacteria isolated, helping to update empirical antibiotic therapy protocols.
This is a prospective comparative observational study on etiologic methods of diagnosis. All the patients, with clinical suspicion, will be submitted to collection of tracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage. These procedures are already incorporated in the daily practice of our intensive cara unit and are routinely performed for investigation of patients with compatible framework of ventilator associated pneumonia, as availability of bronchoscopist.
Whereas an analysis of variance will be performed to compare the three interventions, with a minimum difference between the treatment means, a power of 0.95 and a significance level of 0.05, with an estimation error of 0.1, will be required a total sample of 72 patients.There will be only one group of 72 patients, in which will be held in all the three samples of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAP suspects | Collect tracheal and pulmonary secretions. All patients (n: 72) will be submitted to endotracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collect tracheal and pulmonary secretions | Procedure | Collect tracheal and pulmonary secretions (endotracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity and accuracy | Sensitivity, specificity and accuracy of noninvasive methods (endotracheal aspirate and non-bronchoscopic bronchoalveolar lavage) in comparison with invasive method (bronchoscopic bronchoalveolar lavage, considered gold standard). Sensitivity: number of true positive cultures obtained with each noninvasive method divided by the number of positive cultures obtained from bronchoscopic bronchoalveolar lavage; Specificity: number of true negative cultures obtained with each noninvasive method divided by the number of negative cultures obtained from bronchoscopic bronchoalveolar lavage; Accuracy: number of true positive plus true negative cultures obtained with each noninvasive method divided by the number of patients (72); | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of ventilator associated pneumonia (cases / time period) | Number of cases of ventilator associated pneumonia divided by the number of months. We hope to reach the number of 72 patients in up to 10 months. | 10 months |
| Antimicrobial susceptibility patterns of bacteria isolated |
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Inclusion Criteria:
Exclusion Criteria:
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All patients older than 18 years admitted to the ICU of Hospital de ClÃnicas de Uberlândia with suspected VAP will be included in the project. from february 2015 to complete the total of 72 patients required, since provided that agree with the terms of informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Melo | Federal University of Uberlandia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rodrigo Miquelanti Melo | Uberlândia | Minas Gerais | 38405320 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15699079 | Background | American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available. | |
| 15913464 | Background |
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We are still collecting data.
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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All positive cultures.
All isolated bacteria will be submitted to tests for antimicrobial susceptibility and resistance pattern. |
| 72-96 hours |
| Kollef MH. What is ventilator-associated pneumonia and why is it important? Respir Care. 2005 Jun;50(6):714-21; discussion 721-4. |
| 15048056 | Background | Tablan OC, Anderson LJ, Besser R, Bridges C, Hajjeh R; CDC; Healthcare Infection Control Practices Advisory Committee. Guidelines for preventing health-care--associated pneumonia, 2003: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR Recomm Rep. 2004 Mar 26;53(RR-3):1-36. |
| 9735080 | Background | Cook DJ, Walter SD, Cook RJ, Griffith LE, Guyatt GH, Leasa D, Jaeschke RZ, Brun-Buisson C. Incidence of and risk factors for ventilator-associated pneumonia in critically ill patients. Ann Intern Med. 1998 Sep 15;129(6):433-40. doi: 10.7326/0003-4819-129-6-199809150-00002. |
| 16215368 | Background | Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review. Crit Care Med. 2005 Oct;33(10):2184-93. doi: 10.1097/01.ccm.0000181731.53912.d9. |
| 18426596 | Background | Rea-Neto A, Youssef NC, Tuche F, Brunkhorst F, Ranieri VM, Reinhart K, Sakr Y. Diagnosis of ventilator-associated pneumonia: a systematic review of the literature. Crit Care. 2008;12(2):R56. doi: 10.1186/cc6877. Epub 2008 Apr 21. |
| 9412561 | Background | Bonten MJ, Bergmans DC, Stobberingh EE, van der Geest S, De Leeuw PW, van Tiel FH, Gaillard CA. Implementation of bronchoscopic techniques in the diagnosis of ventilator-associated pneumonia to reduce antibiotic use. Am J Respir Crit Care Med. 1997 Dec;156(6):1820-4. doi: 10.1164/ajrccm.156.6.9610117. |
| 10766680 | Background | Fagon JY, Chastre J, Wolff M, Gervais C, Parer-Aubas S, Stephan F, Similowski T, Mercat A, Diehl JL, Sollet JP, Tenaillon A. Invasive and noninvasive strategies for management of suspected ventilator-associated pneumonia. A randomized trial. Ann Intern Med. 2000 Apr 18;132(8):621-30. doi: 10.7326/0003-4819-132-8-200004180-00004. |
| 7500408 | Background | Croce MA, Fabian TC, Schurr MJ, Boscarino R, Pritchard FE, Minard G, Patton JH Jr, Kudsk KA. Using bronchoalveolar lavage to distinguish nosocomial pneumonia from systemic inflammatory response syndrome: a prospective analysis. J Trauma. 1995 Dec;39(6):1134-9; discussion 1139-40. doi: 10.1097/00005373-199512000-00022. |
| 18381016 | Background | Leo A, Galindo-Galindo J, Folch E, Guerrero A, Bosques F, Mercado R, Arroliga AC. Comparison of bronchoscopic bronchoalveolar lavage vs blind lavage with a modified nasogastric tube in the etiologic diagnosis of ventilator-associated pneumonia. Med Intensiva. 2008 Apr;32(3):115-20. doi: 10.1016/s0210-5691(08)70921-5. |
| 15644647 | Background | Shorr AF, Sherner JH, Jackson WL, Kollef MH. Invasive approaches to the diagnosis of ventilator-associated pneumonia: a meta-analysis. Crit Care Med. 2005 Jan;33(1):46-53. doi: 10.1097/01.ccm.0000149852.32599.31. |
| 17182987 | Background | Canadian Critical Care Trials Group. A randomized trial of diagnostic techniques for ventilator-associated pneumonia. N Engl J Med. 2006 Dec 21;355(25):2619-30. doi: 10.1056/NEJMoa052904. |
| 16698740 | Background | Fujitani S, Yu VL. Diagnosis of ventilator-associated pneumonia: focus on nonbronchoscopic techniques (nonbronchoscopic bronchoalveolar lavage, including mini-BAL, blinded protected specimen brush, and blinded bronchial sampling) and endotracheal aspirates. J Intensive Care Med. 2006 Jan-Feb;21(1):17-21. doi: 10.1177/0885066605283094. |
| 1424930 | Background | Meduri GU, Chastre J. The standardization of bronchoscopic techniques for ventilator-associated pneumonia. Chest. 1992 Nov;102(5 Suppl 1):557S-564S. doi: 10.1378/chest.102.5_supplement_1.557s. No abstract available. |
| 1424932 | Background | Baselski VS, el-Torky M, Coalson JJ, Griffin JP. The standardization of criteria for processing and interpreting laboratory specimens in patients with suspected ventilator-associated pneumonia. Chest. 1992 Nov;102(5 Suppl 1):571S-579S. doi: 10.1378/chest.102.5_supplement_1.571s. No abstract available. |
| 9476845 | Background | Sanchez-Nieto JM, Torres A, Garcia-Cordoba F, El-Ebiary M, Carrillo A, Ruiz J, Nunez ML, Niederman M. Impact of invasive and noninvasive quantitative culture sampling on outcome of ventilator-associated pneumonia: a pilot study. Am J Respir Crit Care Med. 1998 Feb;157(2):371-6. doi: 10.1164/ajrccm.157.2.97-02039. |
| 12887949 | Background | Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC; Standards for Reporting of Diagnostic Accuracy. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Clin Radiol. 2003 Aug;58(8):575-80. doi: 10.1016/s0009-9260(03)00258-7. |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |