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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 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05589727
Study type Observational
Source Hospital Alemão Oswaldo Cruz
Contact Giovanna M Nascimento, MD
Phone 11 3549-0581
Email gmnascimento@haoc.com.br
Status Recruiting
Phase
Start date October 21, 2022
Completion date January 21, 2024
View Details
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