Ventilator-Associated Pneumonia Clinical Trial
Official title:
Study to Validate the Application of the Epidemiological Diagnostic Criteria of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified to the Brazilian Health Regulatory Agency (ANVISA)
Multicentric observational prospective cohort study in 15 (fifteen) hospitals representing all Brazilian regions. The main objective of this project is to evaluate the incidence of Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria for VAP versus VAE criteria defined by the National Healthcare Safety Network (NHSN). The diagnostic accuracy of the two criteria for identifying VAP will also be compared, characterizing other events associated with mechanical ventilation that are not VAP, when applicable. The study also aims to adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria.
Status | Recruiting |
Enrollment | 226 |
Est. completion date | January 21, 2024 |
Est. primary completion date | December 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients aged 18 years or older - Pacients hospitalized in intensive care units (ICUs) using mechanical ventilation Exclusion Criteria: - Patients withdrawn from mechanical ventilation (MV) on the first day (D1) or second day (D2), with D1 being the day of initiation of MV; - Patients with hospital discharge (discharge, death or transfer) on D1 or D2 of mechanical ventilation |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Jean Bittar | Belém | Pará |
Brazil | Hospital Universitário de Brasília | Brasília | Distrito Federal |
Brazil | Hospital Geral de Caxias do Sul | Caxias Do Sul | Rio Do Grande Do Sul |
Brazil | Hospital OTOclínica | Fortaleza | Ceará |
Brazil | Hospital Geral de Goiânia Alberto Rassi | Goiânia | Goiás |
Brazil | Hospital Municipal de Maringá | Maringá | Paraná |
Brazil | Hospital do Tricentenário | Olinda | Pernambuco |
Brazil | Hospital Regional Público do Leste do Pará | Paragominas | Pará |
Brazil | Hospital Ernesto Dornelles | Porto Alegre | Rio Grande Do Sul |
Brazil | Instituto Estadual do Cérebro Paulo Niemeyer | Rio De Janeiro | |
Brazil | Hospital Regional do Baixo Amazonas do Pará | Santarém | Pará |
Brazil | Hospital Presidente Vargas | São Luís | Maranhão |
Brazil | A. C. Camargo Cancer Center | São Paulo | |
Brazil | Hospital Aviccena | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital Alemão Oswaldo Cruz | Ministry of Health, Brazil |
Brazil,
Donner A, Eliasziw M. A goodness-of-fit approach to inference procedures for the kappa statistic: confidence interval construction, significance-testing and sample size estimation. Stat Med. 1992 Aug;11(11):1511-9. doi: 10.1002/sim.4780111109. — View Citation
Fan Y, Gao F, Wu Y, Zhang J, Zhu M, Xiong L. Does ventilator-associated event surveillance detect ventilator-associated pneumonia in intensive care units? A systematic review and meta-analysis. Crit Care. 2016 Oct 24;20(1):338. doi: 10.1186/s13054-016-1506-z. — View Citation
Hebert C, Flaherty J, Smyer J, Ding J, Mangino JE. Development and validation of an automated ventilator-associated event electronic surveillance system: A report of a successful implementation. Am J Infect Control. 2018 Mar;46(3):316-321. doi: 10.1016/j.ajic.2017.09.006. Epub 2017 Nov 10. — View Citation
Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available. Erratum In: Am J Infect Control. 2008 Nov;36(9):655. — View Citation
Klompas M. The paradox of ventilator-associated pneumonia prevention measures. Crit Care. 2009;13(5):315. doi: 10.1186/cc8036. Epub 2009 Oct 15. — View Citation
Klompas M. Ventilator-Associated Events: What They Are and What They Are Not. Respir Care. 2019 Aug;64(8):953-961. doi: 10.4187/respcare.07059. — View Citation
Raoof S, Baumann MH; Critical Care Societies Collaborative, consisting of the leadership of the American Association of Critical-Care Nurses, the American College of Chest Physicians, the American Thoracic Society, and the Society of Critical Care Medicine. Ventilator-associated events: the new definition. Am J Crit Care. 2014 Jan;23(1):7-9. doi: 10.4037/ajcc2014469. No abstract available. — View Citation
Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68. — View Citation
Stevens JP, Silva G, Gillis J, Novack V, Talmor D, Klompas M, Howell MD. Automated surveillance for ventilator-associated events. Chest. 2014 Dec;146(6):1612-1618. doi: 10.1378/chest.13-2255. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Ventilator-Associated Pneumonia (VAP) using two different surveillance criteria. | To evaluate the incidence of Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria for VAP versus the criteria for events Ventilator-Associated Events (VAE) defined by the NHSN. | through study completion, an average of 6 months | |
Secondary | Accuracy of the two criteria for identifying VAP | The diagnostic accuracy of the two criteria for identifying VAP will also be compared, characterizing other events associated with mechanical ventilation other than VAP, when applicable - Ventilator-Associated Condition (VAC), Infection-related Ventilator-Associated Complication (IVAC), Possible Ventilator-Associated Pneumonia (PVAP). | through study completion, an average of 6 months | |
Secondary | Adjudication of VAP | To adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria. | through study completion, an average of 6 months |
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