Application of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified in Brazil

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.

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Key information

Conditions

Ventilator-associated Pneumonia Cross Infection Disease Attributes Healthcare Associated Infection Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital São Vicente de Paula, Barbalha, Ceará, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Incidence of Ventilator-Associated Pneumonia (VAP) using two different surveillance criteria.

Time frame: 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 outcomes

Accuracy of the two criteria for identifying VAP

Time frame: 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

Time frame: through study completion, an average of 6 months

To adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria.

Sponsors and collaborators

Lead sponsor

Giovanna Marssola Nascimento

Other

Collaborators

Ministry of Health, Brazil

Registry information

Official study title

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)

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2024
First posted: Oct 21, 2022
Registry last updated: Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed