Application of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified in Brazil
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The study will be carried out in about 15 centers, comprising the five Brazilian regions. It will be conducted from October 2022 to June 2023. 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) and diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) between the two criteria will be analyzed.
The microbiological profiles of VAP cultures will be described
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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Patients with VAP - ANVISA criteria Patients notified with Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria. |
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Patients with VAP - NHSN criteria Patients notified with Ventilator-Associated Pneumonia (VAP) when using the Ventilator-Associated Events (VAE) criteria defined by the NHSN. |
Outcome Measures
Primary Outcome Measures
- Incidence of Ventilator-Associated Pneumonia (VAP) using two different surveillance criteria. [through study completion, an average of 6 months]
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.
Secondary Outcome Measures
- Accuracy of the two criteria for identifying VAP [through study completion, an average of 6 months]
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).
- Adjudication of VAP [through study completion, an average of 6 months]
To adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged 18 years or older
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Pacients hospitalized in intensive care units (ICUs) using mechanical ventilation
Exclusion Criteria:
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Patients withdrawn from mechanical ventilation (MV) on the first day (D1) or second day (D2), with D1 being the day of initiation of MV;
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Patients with hospital discharge (discharge, death or transfer) on D1 or D2 of mechanical ventilation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital OTOclínica | Fortaleza | Ceará | Brazil | |
2 | Hospital Universitário de Brasília | Brasília | Distrito Federal | Brazil | |
3 | Hospital Geral de Goiânia Alberto Rassi | Goiânia | Goiás | Brazil | |
4 | Hospital Presidente Vargas | São Luís | Maranhão | Brazil | |
5 | Hospital Municipal de Maringá | Maringá | Paraná | Brazil | |
6 | Hospital Jean Bittar | Belém | Pará | Brazil | |
7 | Hospital Regional Público do Leste do Pará | Paragominas | Pará | Brazil | |
8 | Hospital Regional do Baixo Amazonas do Pará | Santarém | Pará | Brazil | |
9 | Hospital do Tricentenário | Olinda | Pernambuco | Brazil | |
10 | Hospital Geral de Caxias do Sul | Caxias Do Sul | Rio Do Grande Do Sul | Brazil | |
11 | Hospital Ernesto Dornelles | Porto Alegre | Rio Grande Do Sul | Brazil | |
12 | Instituto Estadual do Cérebro Paulo Niemeyer | Rio De Janeiro | Brazil | ||
13 | A. C. Camargo Cancer Center | São Paulo | Brazil | ||
14 | Hospital Aviccena | São Paulo | Brazil |
Sponsors and Collaborators
- Hospital Alemão Oswaldo Cruz
- Ministry of Health, Brazil
Investigators
- Principal Investigator: Giovanna M Nascimento, MD, Hospital Alemão Oswaldo Cruz
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- Klompas M. The paradox of ventilator-associated pneumonia prevention measures. Crit Care. 2009;13(5):315. doi: 10.1186/cc8036. Epub 2009 Oct 15.
- 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.
- 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.
- Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68.
- 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.
- IMPACTO MR-PAV