Application of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified in Brazil

NCT05589727 | Completed DMC

• 1 other identifier: IMPACTO MR-PAV
• Study Type: observational
• Target: 987
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Ventilator-Associated Pneumonia; Healthcare-Associated Pneumonia; Healthcare Associated Infection

Keywords

pneumonia; surveillance; healthcare associated infections; Ventilator-Associated Pneumonia; Healthcare-Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Accuracy of the two criteria for identifying VAP

  through study completion, an average of 6 months

• Adjudication of VAP

  through study completion, an average of 6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients aged 18 years or older who are hospitalized in intensive care units (ICUs) using mechanical ventilation.

You may qualify if:

• Patients aged 18 years or older
• Pacients hospitalized in intensive care units (ICUs) using mechanical ventilation

You may not qualify if:

• 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

Sponsors & Collaborators

• Giovanna Marssola Nascimento: lead
• Ministry of Health, Brazil: collaborator

Study Sites (12)

Hospital São Vicente de Paula

Barbalha, Ceará, Brazil

Location

Hospital OTOclínica

Fortaleza, Ceará, Brazil

Location

Hospital Universitário de Brasília

Brasília, Federal District, Brazil

Location

Hospital Geral de Goiânia Alberto Rassi

Goiânia, Goiás, Brazil

Location

Hospital Presidente Vargas

São Luís, Maranhão, Brazil

Location

Hospital Municipal de Maringá

Maringá, Paraná, Brazil

Location

Hospital Jean Bittar

Belém, Pará, Brazil

Location

Hospital do Tricentenário

Olinda, Pernambuco, Brazil

Location

Instituto Estadual do Cérebro Paulo Niemeyer

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital Geral de Caxias do Sul

Caxias do Sul, Rio Do Grande Do Sul, Brazil

Location

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, Brazil

Location

A. C. Camargo Cancer Center

São Paulo, São Paulo, Brazil

Location

Related Publications (11)

• 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.

  PMID: 18538699 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.

  PMID: 31346070 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.

  PMID: 19849825 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.

  PMID: 27772529 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.

  PMID: 24382609 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.

  PMID: 25451350 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.

  PMID: 29132696 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.

  PMID: 15733050 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.

  PMID: 1410963 BACKGROUND

• 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.

  PMID: 40409133 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.

  PMID: 38070904 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giovanna M Nascimento, MD

  Hospital Alemão Oswaldo Cruz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 21, 2022
• Study Start: October 21, 2022
• Primary Completion: December 21, 2023
• Study Completion: January 21, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (12)