- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06917521
VAP Identification by AI (AI-VAP)
August 22, 2025 updated by: Ente Ospedaliero Cantonale, Bellinzona
EARLY IDENTIFICATION OF VENTILATOR ASSOCIATED PNEUMONIA USING MACHINE LEARNING TECHNIQUES: A PROSPECTIVE COHORT
Ventilator-associated pneumonia (VAP) is the most frequent infection in the intensive care setting.
For VAP there is currently no reliable diagnostic criteria.
We aimed with the present study, using data from the mechanical ventilator to identify early this infection using artificial intelligence methods .
Study Overview
Status
Completed
Conditions
Detailed Description
Ventilator-associated pneumonia (VAP) is defined as a hospital-acquired pneumonia occurring in patients submitted to invasive mechanical ventilation (MV) for at least 48 hours.
VAP represents the most prevalent nosocomial infection in the intensive care setting.
VAP is burdened by prolonged duration of MV and hospital length of stay and consequently increases hospital costs.
Moreover, mortality and antibiotic use are also significantly affected.
Unfortunately, there is currently no valid, accurate diagnostic criteria of VAP because even the most widely used ones are neither sensitive nor specific..
The insufficient sensitivity of these criteria to rule out VAP carries the risk of antibiotic overuse with the consequently emerging of antibiotic resistance and superinfections.
On the other hand, the insufficient specificity to rule in VAP carries the risk of delayed administration of antimicrobial therapy leading to increased mortality.
Ventilator-associated event surveillance failed to accurately identify VAP, too .
The purpose of the present study is to develop different AI-algorithms using data continuously recorded form the mechanical ventilator in supporting clinicians for the early detection of VAP.
An accurate AI-algorithm for early VAP identification has the potential to reduce morbidity, mortality, exposure to broad-spectrum and/or unnecessary antibiotics and finally to reduce costs.
Study Type
Observational
Enrollment (Actual)
76
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ticino
-
Lugano, Ticino, Switzerland, 6900
- Ospedale civico Lugano
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All consecutive adult patients admitted to our ICU requiring invasive respiratory support for at least 48 hours will be enrolled
Description
Inclusion Criteria:
- adult patients admitted to our ICU requiring invasive respiratory support for at least 48 hours
Exclusion Criteria:
- previuos pneumonia
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early identification of VAP
Time Frame: From July 2023 to Mars 2025
|
Sensitivity, specificity, AUROC and AUPRC
|
From July 2023 to Mars 2025
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
July 1, 2023
Primary Completion (Actual)
March 1, 2025
Study Completion (Actual)
June 15, 2025
Study Registration Dates
First Submitted
April 1, 2025
First Submitted That Met QC Criteria
April 1, 2025
First Posted (Actual)
April 8, 2025
Study Record Updates
Last Update Posted (Actual)
August 24, 2025
Last Update Submitted That Met QC Criteria
August 22, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-00624 CE 4085
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.