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

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05589727
• Other study ID #: IMPACTO MR-PAV
• Status: Recruiting
• Start date: October 21, 2022
• Est. completion date: January 21, 2024

Study information

• Verified date: October 2023
• Source: Hospital Alemão Oswaldo Cruz
• Contact: Giovanna M Nascimento, MD
• Phone: 11 3549-0581
• Email: gmnascimento[@]haoc.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Alemão Oswaldo Cruz	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

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

Outcome

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

External Links

•   Agência Nacional de Vigilância Sanitária (Anvisa). Critérios Diagnósticos de Infecções Relacionadas à Assistência à Saúde. Brasília: Anvisa; 2022