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COMPLETED

NCT07742943

Clinical Validation of Vital-PICASO for Predicting Cardiac Arrest Within 24 Hours

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 in-hospital cardiac arrest within 24 hours using vital-sign data collected 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. Vital-sign variables include systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and, when available, oxygen saturation. Eligible data will be classified as cardiac arrest-positive or cardiac arrest-negative according to predefined reference-standard criteria. The blinded datasets will then be analyzed using Vital-PICASO, and the software-generated risk scores will be compared with the reference-standard classifications. Predictive performance will be evaluated separately using models that include oxygen saturation and models that do not include oxygen saturation.

Official title: Clinical Validity of an AI-Based Biological Signal Analysis Software Vital-PICASO for Predicting the Risk of Cardiac Arrest 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

387

Start Date

2025-08-20

Completion Date

2025-12-19

Last Updated

2026-08-03

Healthy Volunteers

Conditions

Heart Arrest

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 * Availability of the required vital-sign data, including systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation when available * Clinical data not previously used in the development of Vital-PICASO Cardiac Arrest-Positive Group * In-hospital cardiac arrest occurred in a general ward * Cardiac arrest was documented in the electronic medical record and was followed by at least one of the following resuscitation procedures: * High-quality cardiopulmonary resuscitation * Defibrillation * Advanced life support * Vital-sign data were available for up to 72 hours before the cardiac arrest * If cardiac arrest occurred within 24 hours after admission to the general ward, all available vital-sign data recorded before the event were included * If a patient experienced multiple cardiac arrest events during the study period, only the first eligible event was included Cardiac Arrest-Negative Group * No cardiac arrest or other predefined clinical deterioration occurred during the selected general ward admission period * The patient was selected from the same general ward as patients in the cardiac arrest-positive group * Vital-sign data were available from a time period comparable with the cardiac arrest-positive group or within 72 hours after admission to the general ward * Only one eligible data segment was included per patient * The data were considered appropriate for inclusion in the cardiac arrest-negative group by the investigator Exclusion Criteria: * Cardiac arrest 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 investigator

Locations (1)

Seoul National University Hospital

Seoul, South Korea