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.
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).
Study Type
OBSERVATIONAL
Enrollment
987
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
...and 2 more locations
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.
Time frame: through study completion, an average of 6 months
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).
Time frame: through study completion, an average of 6 months
Adjudication of VAP
To adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria.
Time frame: through study completion, an average of 6 months
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