Clinical Validation of Vital-PICASO for Predicting Cardiac Arrest Within 24 Hours (NCT07742943) | Clinical Trial Compass
CompletedNot Applicable
Clinical Validation of Vital-PICASO for Predicting Cardiac Arrest Within 24 Hours
South Korea387 participantsStarted 2025-08-20
Plain-language summary
The purpose of this retrospective study is to evaluate the clinical performance of Vital-PICASO, an artificial intelligence-based biological signal analysis software designed to predict the risk of in-hospital cardiac arrest within 24 hours using vital-sign data collected from adult general ward inpatients.
Electronic medical record data from patients aged 19 years or older who were admitted to a general ward at Seoul National University Hospital will be retrospectively reviewed. Vital-sign variables include systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and, when available, oxygen saturation.
Eligible data will be classified as cardiac arrest-positive or cardiac arrest-negative according to predefined reference-standard criteria. The blinded datasets will then be analyzed using Vital-PICASO, and the software-generated risk scores will be compared with the reference-standard classifications. Predictive performance will be evaluated separately using models that include oxygen saturation and models that do not include oxygen saturation.
Who can participate
Age range
19 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
General Criteria
* Male or female patient aged 19 years or older at the time the clinical data were recorded
* Electronic medical record data available between January 1, 2023, and May 31, 2025
* Admission to a general ward for at least 12 hours
* Availability of the required vital-sign data, including systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation when available
* Clinical data not previously used in the development of Vital-PICASO
Cardiac Arrest-Positive Group
* In-hospital cardiac arrest occurred in a general ward
* Cardiac arrest was documented in the electronic medical record and was followed by at least one of the following resuscitation procedures:
* High-quality cardiopulmonary resuscitation
* Defibrillation
* Advanced life support
* Vital-sign data were available for up to 72 hours before the cardiac arrest
* If cardiac arrest occurred within 24 hours after admission to the general ward, all available vital-sign data recorded before the event were included
* If a patient experienced multiple cardiac arrest events during the study period, only the first eligible event was included
Cardiac Arrest-Negative Group
* No cardiac arrest or other predefined clinical deterioration occurred during the selected general ward admission period
* The patient was selected from the same general ward as patients in the cardiac arrest-positive group
* Vital-sign data were available from a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AUROC for 24-Hour Cardiac Arrest Prediction Using Vital Signs Including SpO2
Timeframe: Up to 72 hours before the cardiac arrest or matched index time
2
AUROC for 24-Hour Cardiac Arrest Prediction Using Vital Signs Excluding SpO2
Timeframe: Up to 72 hours before the cardiac arrest or matched index time