Ventilator-Associated EventPA in VA-LRTIsNCT04727957
Predictive Analytics in Lower Respiratory Tract Infections (VA-LRTIs)
An observational study of Ventilator-Associated Event, run by University of Oulu at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilator-Associated Event
- What is being tested?
- Diagnostic and prognostic models for VA-LRTIs
- How many people
- 30,000 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult mixed medical-surgical ICU patients
All invasively ventilated ICU patient (aged 18 or over)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ventilator-Associated Event
- Being tested
- Diagnostic and prognostic models for VA-LRTIs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic and prognostic models for VA-LRTIsOther
Diagnostic and prognostic models for VA-LRTIs
| Study group | Role | What they receive |
|---|---|---|
| Dataset for development and testing | Not described Receives: Other: Diagnostic and prognostic models for VA-LRTIs | |
| Dataset for external validation | Not described Receives: Other: Diagnostic and prognostic models for VA-LRTIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with VA-LRTI as assessed by risk-calculator
Prediction model to be used at the moment of diagnosis and algorithms to be used prior IMV to predict the risk of VA-LRTI.
Measured: 1.6.-31.12.2021
Secondary outcomes (1)
Rate of in-hospital mortality
Prediction model to be used at the moment of diagnosis to predict the risk of mortality in VA-LRTIs.
Measured: 1.6.-31.12.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miia M Jansson, PhD, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727957
- Sponsor's protocol ID
- University of Oulu
- Acronym
- PA in VA-LRTIs
- Status last verified
- Apr 2021
- First submitted
- 5 Jan 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Analytics in Ventilator-Associated Events
- ClinicalTrials.gov ID
- NCT04727957
- Acronym / sponsor ID
- PA in VA-LRTIs / University of Oulu
- Conditions
- Ventilator-Associated Event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dataset for development and testing | – | Other: Diagnostic and prognostic models for VA-LRTIs |
| Dataset for external validation | – | Other: Diagnostic and prognostic models for VA-LRTIs |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult mixed medical-surgical ICU patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic and prognostic models for VA-LRTIsDiagnostic and prognostic models for VA-LRTIs | Other | Dataset for development and testing, Dataset for external validation |
Primary outcome
Number of participants with VA-LRTI as assessed by risk-calculator
Time frame: 1.6.-31.12.2021
Prediction model to be used at the moment of diagnosis and algorithms to be used prior IMV to predict the risk of VA-LRTI.
1 secondary outcome
Rate of in-hospital mortality
Time frame: 1.6.-31.12.2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Ventilator-Associated Events
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Associated Event, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miia Jansson, PhD (+358 50 470 12 62, miia.jansson@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with VA-LRTI as assessed by risk-calculator (time frame: 1.6.-31.12.2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.