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

NCT07742813 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2250

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Huinno AIM

    lead INDUSTRY

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2026-06-12
Completion
2026-07-07

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07742813 on ClinicalTrials.gov