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NCT07742813

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

Sponsor: Huinno AIM

View on ClinicalTrials.gov

Summary

The purpose of this retrospective study is to evaluate the clinical performance of Vital-PICASO, an artificial intelligence-based biological signal analysis software designed to predict the risk of hypoxia 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 will be retrospectively reviewed. Hypoxia will be evaluated using two separate reference-standard criteria: oxygen saturation below 94% and administration of oxygen at 4 L/min or more. Eligible hypoxia-positive and hypoxia-negative datasets will be randomly selected. The selected vital-sign datasets will be analyzed using Vital-PICASO while the device operator is blinded to the reference-standard classification. The software-generated hypoxia risk scores will be compared with the reference-standard classifications to evaluate predictive performance. Because the study uses previously collected medical records, there is no direct participant contact and the software results will not affect patient care.

Official title: Clinical Validity of an AI-Based Biological Signal Analysis Software Vital-PICASO for Predicting the Risk of Hypoxia Within 24 Hrs 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

2250

Start Date

2025-08-20

Completion Date

2026-07-07

Last Updated

2026-08-03

Healthy Volunteers

No

Conditions

Locations (1)

Seoul National University Hospital

Seoul, South Korea