Ventilator Associated Pneumonia Clinical Trial
Official title:
Prospective Comparative Study of Different Etiologic Diagnostic Methods in Ventilator Associated Pneumonia (VAP)
NCT number | NCT02363023 |
Other study ID # | VAP protocol |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | June 2016 |
Verified date | May 2018 |
Source | Federal University of Uberlandia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 30 |
Est. completion date | June 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Older than 18 and clinical suspicion of VAP; Exclusion Criteria: - Age less than 18 years; - Introduction or modification of antibiotic therapy due to associated diagnosis in the first 3 days of the start of the protocol; - No agreement with informed consent or for any other reason, expose the desire to leave the protocol at any time. |
Country | Name | City | State |
---|---|---|---|
Brazil | Rodrigo Miquelanti Melo | Uberlandia | Minas Gerais |
Lead Sponsor | Collaborator |
---|---|
Federal University of Uberlandia |
Brazil,
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Fagon JY, Chastre J, Wolff M, Gervais C, Parer-Aubas S, Stéphan 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. — View Citation
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. Review. — View Citation
Kollef MH. What is ventilator-associated pneumonia and why is it important? Respir Care. 2005 Jun;50(6):714-21; discussion 721-4. — View Citation
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. — View Citation
Meduri GU, Chastre J. The standardization of bronchoscopic techniques for ventilator-associated pneumonia. Chest. 1992 Nov;102(5 Suppl 1):557S-564S. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Sanchez-Nieto JM, Torres A, Garcia-Cordoba F, El-Ebiary M, Carrillo A, Ruiz J, Nuñez 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. Erratum in: Am J Respir Crit Care Med 1998 Mar;157(3 Pt 1):1005. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Antimicrobial susceptibility patterns of bacteria isolated | All isolated bacteria will be submitted to tests for antimicrobial susceptibility and resistance pattern. | 72-96 hours |
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