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

October 30, 2023 updated by: Giovanna Marssola Nascimento, Hospital Alemão Oswaldo Cruz

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)

Multicentric observational prospective cohort study in 15 (fifteen) 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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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 described

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).

Study Type

Observational

Enrollment (Estimated)

226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil
        • Recruiting
        • Instituto Estadual do Cérebro Paulo Niemeyer
        • Contact:
      • São Paulo, Brazil
      • São Paulo, Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil
        • Not yet recruiting
        • Hospital Universitário de Brasília
        • Contact:
    • Goiás
      • Goiânia, Goiás, Brazil
        • Recruiting
        • Hospital Geral de Goiânia Alberto Rassi
        • Contact:
    • Maranhão
      • São Luís, Maranhão, Brazil
        • Recruiting
        • Hospital Presidente Vargas
        • Contact:
    • Paraná
      • Maringá, Paraná, Brazil
        • Recruiting
        • Hospital Municipal de Maringá
        • Contact:
    • Pará
    • Pernambuco
      • Olinda, Pernambuco, Brazil
        • Recruiting
        • Hospital do Tricentenário
        • Contact:
    • Rio Do Grande Do Sul
      • Caxias Do Sul, Rio Do Grande Do Sul, Brazil
        • Recruiting
        • Hospital Geral de Caxias do Sul
        • Contact:
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Recruiting
        • Hospital Ernesto Dornelles
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients aged 18 years or older who are hospitalized in intensive care units (ICUs) using mechanical ventilation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with VAP - ANVISA criteria
Patients notified with Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria.
Patients with VAP - NHSN criteria
Patients notified with Ventilator-Associated Pneumonia (VAP) when using the Ventilator-Associated Events (VAE) criteria defined by the NHSN.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
through study completion, an average of 6 months
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.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Alemão Oswaldo Cruz

Collaborators

Ministry of Health, Brazil

Investigators

  • Principal Investigator: Giovanna M Nascimento, MD, Hospital Alemao Oswaldo Cruz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2022

Primary Completion (Estimated)

December 21, 2023

Study Completion (Estimated)

January 21, 2024

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPACTO MR-PAV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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