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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 987
- 试验地点
- 12
- 主要终点
- Incidence of Ventilator-Associated Pneumonia (VAP) using two different surveillance criteria.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older
- •Pacients hospitalized in intensive care units (ICUs) using mechanical ventilation
排除标准
- •Patients withdrawn from mechanical ventilation (MV) on the first day (D1) or second day (D2), with D1 being the day of initiation of MV;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
结局指标
主要结局
Incidence of Ventilator-Associated Pneumonia (VAP) using two different surveillance criteria.
时间窗: 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.
次要结局
- Accuracy of the two criteria for identifying VAP(through study completion, an average of 6 months)
- Adjudication of VAP(through study completion, an average of 6 months)
研究者
Giovanna Marssola Nascimento
Principal Investigator
Hospital Alemão Oswaldo Cruz