Clinical Validation of Vital-PICASO for Predicting Hypotension Within 24 Hours in General Ward Inpatients

Completed

Conditions studied: Hypotension

In brief

This retrospective study evaluated the clinical performance of Vital-PICASO, an artificial intelligence-based biological signal analysis software designed to predict the risk of hypotension 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 were retrospectively reviewed. Hypotension was defined as systolic blood pressure below 90 mmHg. Eligible data were classified as hypotension-positive or hypotension-negative according to predefined reference-standard criteria. Vital-PICASO was applied to the selected vital-sign datasets, and the software-generated hypotension risk scores were compared with the reference-standard classifications. Predictive performance was evaluated separately using data that included oxygen saturation and data that excluded oxygen saturation. Because the study used previously collected medical records, there was no direct participant contact and the software results were not used to guide patient care.

Key facts

Study ID

NCT07742930

Run by

Huinno AIM

People needed

648

Starts

2025-07-21

Expected to finish

2026-05-13

Last updated by the study team

2026-08-03

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Hypotension-Positive Group
• Hypotension occurred in a general ward
• Hypotension was defined as systolic blood pressure below 90 mmHg
• Vital-sign data were available for up to 72 hours before the hypotension event
• If hypotension occurred within 24 hours after admission or transfer to the general ward, all available vital-sign data recorded before the event were included
• If a patient experienced multiple hypotension events during the data collection period, only the first eligible event was included
• Hypotension-Negative Group
• No hypotension occurred during the selected general ward admission period
• Data were randomly selected from the same general wards as the hypotension-positive group
• Vital-sign data were available from a time interval comparable with the hypotension event reference time or for up to 72 hours after admission to the general ward
• Only one eligible data interval was included per patient
• The data were considered appropriate for inclusion in the hypotension-negative group by the investigator

You may not qualify if…

• Hypotension occurred outside a general ward
• A do-not-resuscitate order was in effect at the time of data collection
• Pregnancy at the time of data collection or within 3 months after delivery
• The data were considered inappropriate for the study by the principal investigator

Where it is running

• Seoul National University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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