Clinical Validity of an AI-Based Biological Signal Analysis Software Vital-PICASO for Predicting the Risk of Hypotension Within 24hrs Using Vital Sign (SBP, DBP, HR, RR, BT, SpO2) From General Ward Inpatients; A Retrospective, Single-Center, Single-Arm, Superiority-Confirmatory Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 648
- Locations
- 1
- Primary Endpoint
- Area Under the Receiver Operating Characteristic Curve for Hypotension Prediction With SpO2
Study Overview
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.
Detailed Description
This study was a retrospective, single-center, superiority-confirmatory clinical performance study conducted at Seoul National University Hospital.
Data Source and Study Population
Electronic medical records were reviewed for patients aged 19 years or older who had been admitted to a general ward for at least 12 hours between January 1, 2023, and May 31, 2025. Clinical data previously used in the development of Vital-PICASO were excluded.
The collected variables included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, oxygen saturation when available, and the corresponding measurement times. Additional variables included the occurrence, time, and location of hypotension; month and year of birth; sex; height and weight when available; do-not-resuscitate status; pregnancy status; date of admission to the general ward; clinical department; and the vital-sign data collection period.
Data Selection
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Area Under the Receiver Operating Characteristic Curve for Hypotension Prediction With SpO2
Time Frame: During the 24-hour period before the hypotension event or corresponding reference time point
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.
Area Under the Receiver Operating Characteristic Curve for Hypotension Prediction Without SpO2
Time Frame: During the 24-hour period before the hypotension event or corresponding reference time point
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.
Secondary Outcomes
- 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)
- Difference Between Vital-PICASO AUROC and the Prespecified NEWS and MEWS Comparator AUROC(During the 24-hour period before the hypotension event or corresponding reference time point)
- Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value at the Selected Risk-Score Threshold(During the 24-hour period before the hypotension event or corresponding reference time point)