NCT05589727

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 987 (actual)
• Sponsor: Giovanna Marssola Nascimento · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Ventilator-Associated Pneumonia
• Healthcare-Associated Pneumonia
• Healthcare Associated Infection

Timeline

• Start date: 2022-10-21
• Primary completion: 2023-12-21
• Completion: 2024-01-21
• First posted: 2022-10-21
• Last updated: 2024-11-20

Locations

12 sites across 1 country: Brazil