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)

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 describedThe 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)..

Medienart:	Klinische Studie

Erscheinungsjahr:	2023
Erschienen:	2023

Enthalten in:	ClinicalTrials.gov - (2023) vom: 31. Okt. Zur Gesamtaufnahme - year:2023

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Cross Infection Healthcare-Associated Pneumonia Pneumonia Pneumonia, Ventilator-Associated Recruitment Status: Recruiting Study Type: Observational

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: October 21, 2022, Last downloaded: ClinicalTrials.gov processed this data on November 08, 2023, Last updated: November 08, 2023

Study ID:

NCT05589727 IMPACTO MR-PAV

Veröffentlichungen zur Studie:

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PPN (Katalog-ID):	CTG008715262