An observational study in Ventilator-Associated Pneumonia, Healthcare-Associated Pneumonia and Healthcare Associated Infection, sponsored by Giovanna Marssola Nascimento. Completed at 12 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Giovanna Marssola Nascimento · Observational
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.
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).
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 987 is above the median of 203 across 688 observational studies indexed under Pneumonia.
Browse Pneumonia studies →This is the only study on the registry with Giovanna Marssola Nascimento as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All patients aged 18 years or older who are hospitalized in intensive care units (ICUs) using mechanical ventilation.
Exclusion Criteria:
Patients notified with Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria.
Patients notified with Ventilator-Associated Pneumonia (VAP) when using the Ventilator-Associated Events (VAE) criteria defined by the NHSN.
Incidence of Ventilator-Associated Pneumonia (VAP) using two different surveillance criteria.
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.
Time frame: through study completion, an average of 6 months
Accuracy of the two criteria for identifying VAP
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).
Time frame: through study completion, an average of 6 months
Adjudication of VAP
To adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria.
Time frame: through study completion, an average of 6 months
Plan to share: No
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.