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NCT07742930

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

Sponsor: Huinno AIM

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

648

Start Date

2025-07-21

Completion Date

2026-05-13

Last Updated

2026-08-03

Healthy Volunteers

No

Conditions

Locations (1)

Seoul National University Hospital

Seoul, South Korea