Clinical Validation of Vital-PICASO for Predicting Hypotension Within 24 Hours in General Ward Inpatients | NCT07742930

NCT07742930

Overview

NCT ID: NCT07742930
Lead Sponsor: Huinno AIMINDUSTRY
Official Title: 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
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.

Status and Timeline

Status: Completed
Last Update Posted: Aug 3, 2026Actual
Start Date: Jul 21, 2025Actual
Primary Completion Date: Apr 1, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 648Actual
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: Seoul National University Hospital

Similar Studies

Participant Group/Arms

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.