- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04727957
Predictive Analytics in Lower Respiratory Tract Infections (VA-LRTIs) (PA in VA-LRTIs)
April 12, 2021 updated by: Miia M Jansson, PhD, University of Oulu
Predictive Analytics in Ventilator-Associated Events
To determine the accuracy and generalizability of VA-LRTI algorithm to detect and predict three high-incidence and high-impact VAEs from electronic health records data: 1) ventilator-associated event, 2) ventilator-associated pneumonia, and 3) ventilator-associated tracheobronchitis.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
30000
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
- Name: Miia Jansson, PhD
- Phone Number: +358 50 470 12 62
- Email: miia.jansson@oulu.fi
Study Locations
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-
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Oulu, Finland
- Univeristy of Oulu
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Contact:
- Miia Jansson, PhD
- Email: miia.jansson@oulu.fi
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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
16 years to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult mixed medical-surgical ICU patients
Description
All invasively ventilated ICU patient (aged 18 or over)
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dataset for development and testing
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Diagnostic and prognostic models for VA-LRTIs
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Dataset for external validation
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Diagnostic and prognostic models for VA-LRTIs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with VA-LRTI as assessed by risk-calculator
Time Frame: 1.6.-31.12.2021
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Prediction model to be used at the moment of diagnosis and algorithms to be used prior IMV to predict the risk of VA-LRTI.
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1.6.-31.12.2021
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of in-hospital mortality
Time Frame: 1.6.-31.12.2021
|
Prediction model to be used at the moment of diagnosis to predict the risk of mortality in VA-LRTIs.
|
1.6.-31.12.2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
January 5, 2021
First Submitted That Met QC Criteria
January 26, 2021
First Posted (Actual)
January 27, 2021
Study Record Updates
Last Update Posted (Actual)
April 15, 2021
Last Update Submitted That Met QC Criteria
April 12, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- University of Oulu
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.
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