Application of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified in Brazil
- Conditions
- Ventilator-Associated PneumoniaHealthcare Associated InfectionHealthcare-Associated Pneumonia
- Registration Number
- NCT05589727
- Lead Sponsor
- Giovanna Marssola Nascimento
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 987
- Patients aged 18 years or older
- Pacients hospitalized in intensive care units (ICUs) using mechanical ventilation
- Patients withdrawn from mechanical ventilation (MV) on the first day (D1) or second day (D2), with D1 being the day of initiation of MV;
- Patients with hospital discharge (discharge, death or transfer) on D1 or D2 of mechanical ventilation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Ventilator-Associated Pneumonia (VAP) using two different surveillance criteria. through study completion, an average of 6 months 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.
- Secondary Outcome Measures
Name Time Method Accuracy of the two criteria for identifying VAP through study completion, an average of 6 months 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).
Adjudication of VAP through study completion, an average of 6 months To adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria.
Trial Locations
- Locations (12)
Hospital São Vicente de Paula
🇧🇷Barbalha, Ceará, Brazil
Hospital OTOclínica
🇧🇷Fortaleza, Ceará, Brazil
Hospital Universitário de Brasília
🇧🇷Brasília, Distrito Federal, 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
Hospital Geral de Caxias do Sul
🇧🇷Caxias Do Sul, Rio do Grande do Sul, Brazil
Hospital Ernesto Dornelles
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Instituto Estadual do Cérebro Paulo Niemeyer
🇧🇷Rio De Janeiro, Brazil
A. C. Camargo Cancer Center
🇧🇷São Paulo, Brazil