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

NCT07742930 | Completed

• 1 other identifier: HA-PI-02
• Study Type: observational
• Target: 648
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypotension

Keywords

Hypotension Prediction; Vital-PICASO; Artificial Intelligence; Biological Signal Analysis Software; Vital Signs; General Ward Inpatients; Systolic Blood Pressure; Oxygen Saturation; Early Warning System; Clinical Decision Support

Outcome Measures

Primary Outcomes (2)

• Area Under the Receiver Operating Characteristic Curve for Hypotension Prediction With SpO2

  The area under the receiver operating characteristic curve (AUROC) was calculated by comparing the hypotension risk scores generated by Vital-PICASO with the reference-standard classification of hypotension-positive or hypotension-negative. The analysis included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation as input variables. Hypotension was defined as systolic blood pressure below 90 mmHg. AUROC ranges from 0 to 1, with a higher value indicating better discrimination. The prespecified success criterion was met if the lower bound of the 95% confidence interval for the difference between the Vital-PICASO AUROC and the comparator AUROC of 0.7847 was greater than 0.

  During the 24-hour period before the hypotension event or corresponding reference time point

• Area Under the Receiver Operating Characteristic Curve for Hypotension Prediction Without SpO2

  The area under the receiver operating characteristic curve (AUROC) was calculated by comparing the hypotension risk scores generated by Vital-PICASO with the reference-standard classification of hypotension-positive or hypotension-negative. The analysis included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature as input variables, without oxygen saturation. Hypotension was defined as systolic blood pressure below 90 mmHg. AUROC ranges from 0 to 1, with a higher value indicating better discrimination. The prespecified success criterion was met if the lower bound of the 95% confidence interval for the difference between the Vital-PICASO AUROC and the comparator AUROC of 0.7847 was greater than 0.

  During the 24-hour period before the hypotension event or corresponding reference time point

Secondary Outcomes (7)

• Area Under the Precision-Recall Curve for Hypotension Prediction With SpO2

  During the 24-hour period before the hypotension event or corresponding reference time point

• Area Under the Precision-Recall Curve for Hypotension Prediction Without SpO2

  During the 24-hour period before the hypotension event or corresponding reference time point

• Precision, Recall, and F1 Score Across Prespecified Risk-Score Thresholds

  During the 24-hour period before the hypotension event or corresponding reference time point

• Predictive Performance by Prediction-Time Interval

  At 0 to 1, 1 to 6, 6 to 12, and 12 to 24 hours before the hypotension event or corresponding reference time point

• Predictive Performance by Cumulative Prediction Window

  Up to 24 hours before the hypotension event or corresponding reference time point

Study Arms (2)

Hypotension-Positive Group

Adult general ward inpatient data with an eligible hypotension event, defined as systolic blood pressure below 90 mmHg, occurring in the general ward. Vital-sign data collected for up to 72 hours before the first eligible hypotension event were included. 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, provided that at least 12 hours of data were available.

Hypotension-Negative Group

Adult general ward inpatient data from patients who did not experience hypotension during the selected general ward admission. Data were randomly selected from the same general wards as the hypotension-positive group and from a time interval comparable with the hypotension event reference time or from up to 72 hours after admission to the general ward. Only one eligible data interval was selected per patient.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consisted of adult patients aged 19 years or older who were admitted to a general ward at Seoul National University Hospital and had at least 12 hours of electronic medical record data available between January 1, 2023, and May 31, 2025. The retrospective study dataset included patients with an eligible hypotension event occurring in a general ward and patients without hypotension during the selected general ward admission period. Hypotension was defined as systolic blood pressure below 90 mmHg.

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

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

Sponsors & Collaborators

• Huinno AIM: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: July 21, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 13, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)