Clinical Validation of Vital-PICASO for Predicting Hypoxia Within 24 Hours in General Ward Inpati… (NCT07742813) | Clinical Trial Compass
CompletedNot Applicable
Clinical Validation of Vital-PICASO for Predicting Hypoxia Within 24 Hours in General Ward Inpatients
South Korea2,250 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 hypoxia within 24 hours using vital-sign data 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. Hypoxia will be evaluated using two separate reference-standard criteria: oxygen saturation below 94% and administration of oxygen at 4 L/min or more.
Eligible hypoxia-positive and hypoxia-negative datasets will be randomly selected. The selected vital-sign datasets will be analyzed using Vital-PICASO while the device operator is blinded to the reference-standard classification. The software-generated hypoxia risk scores will be compared with the reference-standard classifications to evaluate predictive performance. Because the study uses previously collected medical records, there is no direct participant contact and the software results will not affect patient care.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
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
* Clinical data not previously used in the development of Vital-PICASO
SpO2-Based Hypoxia-Positive Group
* Hypoxia occurred in a general ward
* Hypoxia was defined as oxygen saturation below 94%
* Vital-sign data were available for up to 72 hours before the hypoxia event
* If hypoxia occurred within 24 hours after admission or transfer to the general ward, all available vital-sign data recorded before the event were included
* If multiple eligible hypoxia events occurred during the data collection period, only the first eligible event was included for this criterion
SpO2-Based Hypoxia-Negative Group
* No hypoxia occurred during the selected general ward admission
* Data were randomly selected from the same general wards as the corresponding hypoxia-positive group
* Vital-sign data were available from a time interval comparable with the hypoxia-event reference time or for up to 72 hours after admission to the general ward
* Only one eligible data interval was included per patient
Oxygen-Treatment-Based Hypoxia-Positive Group
* Hypoxia occurred in a general ward
* Hypoxia was defined as oxygen administration at a flow rate of 4 L/min or more
* Vital-sign data were available for up to 72 hours before the initi…
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
Area Under the Receiver Operating Characteristic Curve for SpO2-Based Hypoxia Prediction
Timeframe: Within 24 hours before the SpO2-based hypoxia event or during the corresponding reference period for negative cases
2
Area Under the Receiver Operating Characteristic Curve for Oxygen-Treatment-Based Hypoxia Prediction
Timeframe: Within 24 hours before oxygen administration at 4 L/min or more or during the corresponding reference period for negative cases