Clinical trial NCT05589727: Application of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified in Brazil
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator-Associated Pneumonia
Healthcare-Associated Pneumonia
Healthcare Associated Infection
Keywords: pneumonia
surveillance
healthcare associated infections
Ventilator-Associated Pneumonia
Healthcare-Associated Pneumonia
Lead sponsor: Hospital Alemão Oswaldo Cruz
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2022-10-21
Enrollment: 987
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients aged 18 years or older who are hospitalized in intensive care units (ICUs) using mechanical ventilation.

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Ventilator-Associated Pneumonia (VAP) using two different surveillance criteria.
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Accuracy of the two criteria for identifying VAP
timeFrame: through study completion, an average of 6 months
measure: Adjudication of VAP
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Barbalha
country: Brazil
facility: Hospital São Vicente de Paula
state: Ceará
city: Fortaleza
country: Brazil
facility: Hospital OTOclínica
state: Ceará
city: Brasília
country: Brazil
facility: Hospital Universitário de Brasília
state: Distrito Federal
city: Goiânia
country: Brazil
facility: Hospital Geral de Goiânia Alberto Rassi
state: Goiás
city: São Luís
country: Brazil
facility: Hospital Presidente Vargas
state: Maranhão
city: Maringá
country: Brazil
facility: Hospital Municipal de Maringá
state: Paraná
city: Belém
country: Brazil
facility: Hospital Jean Bittar
state: Pará
city: Olinda
country: Brazil
facility: Hospital do Tricentenário
state: Pernambuco
city: Caxias Do Sul
country: Brazil
facility: Hospital Geral de Caxias do Sul
state: Rio do Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
state: Rio Grande do Sul
city: Rio De Janeiro
country: Brazil
facility: Instituto Estadual do Cérebro Paulo Niemeyer
city: São Paulo
country: Brazil
facility: A. C. Camargo Cancer Center
Study officials:
affiliation: Hospital Alemão Oswaldo Cruz
name: Giovanna M Nascimento, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
citation: 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.