CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 987 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT05589727
NCT05589727N/ACompleted

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)

Giovanna Marssola Nascimento·observational·Posted Oct 21, 2022·Updated Nov 20, 2024

In Brief

An observational study for Ventilator-Associated Pneumonia and 2 related conditions. Completed, enrolled 987 participants across 12 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
2023202420252026
First PostedOct 21, 2022
Enrollment StartOct 21, 2022
Primary CompletionDec 21, 2023
Study CompletionJan 21, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.7 years ago