Application of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified in Brazil
NCT ID: NCT05589727
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
987 participants
OBSERVATIONAL
2022-10-21
2024-01-21
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with VAP - ANVISA criteria
Patients notified with Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria.
No interventions assigned to this group
Patients with VAP - NHSN criteria
Patients notified with Ventilator-Associated Pneumonia (VAP) when using the Ventilator-Associated Events (VAE) criteria defined by the NHSN.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Pacients hospitalized in intensive care units (ICUs) using mechanical ventilation
Exclusion Criteria
* Patients with hospital discharge (discharge, death or transfer) on D1 or D2 of mechanical ventilation
18 Years
ALL
No
Sponsors
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Ministry of Health, Brazil
OTHER_GOV
Giovanna Marssola Nascimento
OTHER
Responsible Party
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Giovanna Marssola Nascimento
Principal Investigator
Principal Investigators
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Giovanna M Nascimento, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Alemão Oswaldo Cruz
Locations
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Hospital São Vicente de Paula
Barbalha, Ceará, Brazil
Hospital OTOclínica
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
Countries
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References
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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.
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.
Klompas M. The paradox of ventilator-associated pneumonia prevention measures. Crit Care. 2009;13(5):315. doi: 10.1186/cc8036. Epub 2009 Oct 15.
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.
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.
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.
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.
Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68.
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.
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.
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.
Other Identifiers
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IMPACTO MR-PAV
Identifier Type: -
Identifier Source: org_study_id
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