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

Sponsor
Hospital Alemão Oswaldo Cruz (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05589727
Collaborator
Ministry of Health, Brazil (Other)
226
14
8
16.1
2

Study Details

Study Description

Brief Summary

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.

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 Design

Study Type:
Observational
Anticipated Enrollment :
226 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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)
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

  2. Adjudication of VAP [through study completion, an average of 6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital OTOclínica Fortaleza Ceará Brazil
2 Hospital Universitário de Brasília Brasília Distrito Federal Brazil
3 Hospital Geral de Goiânia Alberto Rassi Goiânia Goiás Brazil
4 Hospital Presidente Vargas São Luís Maranhão Brazil
5 Hospital Municipal de Maringá Maringá Paraná Brazil
6 Hospital Jean Bittar Belém Pará Brazil
7 Hospital Regional Público do Leste do Pará Paragominas Pará Brazil
8 Hospital Regional do Baixo Amazonas do Pará Santarém Pará Brazil
9 Hospital do Tricentenário Olinda Pernambuco Brazil
10 Hospital Geral de Caxias do Sul Caxias Do Sul Rio Do Grande Do Sul Brazil
11 Hospital Ernesto Dornelles Porto Alegre Rio Grande Do Sul Brazil
12 Instituto Estadual do Cérebro Paulo Niemeyer Rio De Janeiro Brazil
13 A. C. Camargo Cancer Center São Paulo Brazil
14 Hospital Aviccena São Paulo Brazil

Sponsors and Collaborators

  • Hospital Alemão Oswaldo Cruz
  • Ministry of Health, Brazil

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Giovanna Marssola Nascimento, Principal Investigator, Hospital Alemão Oswaldo Cruz
ClinicalTrials.gov Identifier:
NCT05589727
Other Study ID Numbers:
  • IMPACTO MR-PAV
First Posted:
Oct 21, 2022
Last Update Posted:
Oct 21, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Giovanna Marssola Nascimento, Principal Investigator, Hospital Alemão Oswaldo Cruz
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2022