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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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Multicentric observational prospective cohort study in 12 (twelve) 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.
The study will be carried out in about 12 centers, comprising the five Brazilian regions. It will be conducted from 2022 to 2024. Data collection will be performed at each center during six months.
Trained health professionals from Infections Control Committees of each participating center will collect data.
Mechanical ventilation data will be entered daily in the database system from the moment the patient is submitted to mechanical ventilation until the first day after the end of mechanical ventilation.
VAPs notified to ANVISA, according to its own criteria, will be reported monthly in the database system for adjudication.
The VAE definition will be performed automatically in the database system by mans of a specific algorithm. The diagnosis established by the system will be manually validated by a nurse with experience in healthcare-associated infection (HAI) surveillance. Agreement variables (Kappa) between the two criteria will be analyzed.
The adjudication will be carried out by two independent professionals (doctor and nurse) with experience in HAIs surveillance. In case of disagreement, there will be an evaluation by a third adjudicator.
The complete project was submitted to the local Institutional Review Board (IRB)/National Research Ethics Commission (CONEP) system and has ethical approval (CAAE: 52354721.0.1001.0070).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with VAP - ANVISA criteria | Patients notified with Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria. | ||
| Patients with VAP - NHSN criteria | Patients notified with Ventilator-Associated Pneumonia (VAP) when using the Ventilator-Associated Events (VAE) criteria defined by the NHSN. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients aged 18 years or older who are hospitalized in intensive care units (ICUs) using mechanical ventilation.
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| Name | Affiliation | Role |
|---|---|---|
| Giovanna M Nascimento, MD | Hospital Alemão Oswaldo Cruz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital São Vicente de Paula | Barbalha | Ceará | Brazil | |||
| Hospital OTOclínica |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18538699 | Background | 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. | |
| 31346070 | Background | 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. |
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| Adjudication of VAP | To adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria. | through study completion, an average of 6 months |
| Fortaleza |
| Ceará |
| Brazil |
| Hospital Universitário de Brasília | Brasília | Federal District | Brazil |
| Hospital Geral de Goiânia Alberto Rassi | Goiânia | Goiás | Brazil |
| Hospital Presidente Vargas | São Luís | Maranhão | Brazil |
| Hospital Municipal de Maringá | Maringá | Paraná | Brazil |
| Hospital Jean Bittar | Belém | Pará | Brazil |
| Hospital do Tricentenário | Olinda | Pernambuco | Brazil |
| Instituto Estadual do Cérebro Paulo Niemeyer | Rio de Janeiro | Rio de Janeiro | Brazil |
| Hospital Geral de Caxias do Sul | Caxias do Sul | Rio Do Grande Do Sul | Brazil |
| Hospital Ernesto Dornelles | Porto Alegre | Rio Grande do Sul | Brazil |
| A. C. Camargo Cancer Center | São Paulo | São Paulo | Brazil |
| 19849825 | Background | Klompas M. The paradox of ventilator-associated pneumonia prevention measures. Crit Care. 2009;13(5):315. doi: 10.1186/cc8036. Epub 2009 Oct 15. |
| 27772529 | Background | 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. |
| 24382609 | Background | 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. |
| 25451350 | Background | 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. |
| 29132696 | Background | 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. |
| 15733050 | Background | Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68. |
| 1410963 | Background | 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. |
| 40409133 | Derived | Nascimento GM, Rodrigues DLG, Piastrelli FT, Cheno MY, Braz KCC, Alves LBO, Tomazini BM, Veiga VC, Arns B, Besen BAMP, Junior APN, Avezum A, da Silva RKL, de Azevedo CMPES, Silva MLSO, Kist GR, Salgado FB, de Moura MTF, Boschi E, Kurtz PMP, Miraglia ERVDS, de Lima TA, Pereira RR, Arraes JA, Alves de Oliveira Junior H. Ventilator-associated events criteria in the assessment of Ventilator-Associated Pneumonia (IMPACTO MR-PAV): A prospective cohort. Braz J Infect Dis. 2025 Jul-Aug;29(4):104543. doi: 10.1016/j.bjid.2025.104543. Epub 2025 May 22. |
| 38070904 | Derived | Nascimento GM, Gomes Rodrigues DL, Mangas Catarino DG, Piastrelli FT, Cheno MY, Braz KCC, Oliveira Alves LB, Avezum A, Veiga VC, Zavascki AP, Tomazini B, Besen B, Pereira AJ, Marques de Pinho APN, De Oliveira Junior HA. Application of ventilator-associated events (VAE) in ventilator-associated pneumonia (VAP) notified in Brazil (IMPACTO MR-PAV): a protocol for a cohort study. BMJ Open. 2023 Dec 9;13(12):e076047. doi: 10.1136/bmjopen-2023-076047. |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D007239 | Infections |
| 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 |
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