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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05589727

Enrollment

987

Registered

2022-10-21

Start date

2022-10-21

Completion date

2024-01-21

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthcare Associated Infection, Healthcare-Associated Pneumonia, Ventilator-Associated Pneumonia

Keywords

pneumonia, surveillance, healthcare associated infections, Ventilator-Associated Pneumonia, Healthcare-Associated Pneumonia

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged 18 years or older * Pacients hospitalized in intensive care units (ICUs) using mechanical ventilation

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Brazil

Outcome results