Clinical Validation of Vital-PICASO for Predicting Hypoxia Within 24 Hours in General Ward Inpatients | NCT07742813

NCT07742813

Overview

NCT ID: NCT07742813
Lead Sponsor: Huinno AIMINDUSTRY
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
Brief 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.

Status and Timeline

Status: Completed
Last Update Posted: Aug 3, 2026Actual
Start Date: Aug 20, 2025Actual
Primary Completion Date: Jun 12, 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

SpO2-Based Hypoxia-Positive Group

Hypoxia occurred in a general ward

Hypoxia was defined as oxygen saturation below 94%

Vital-sign data were available for up to 72 hours before the hypoxia event

If hypoxia occurred within 24 hours after admission or transfer to the general ward, all available vital-sign data recorded before the event were included

If multiple eligible hypoxia events occurred during the data collection period, only the first eligible event was included for this criterion

SpO2-Based Hypoxia-Negative Group

No hypoxia occurred during the selected general ward admission

Data were randomly selected from the same general wards as the corresponding hypoxia-positive group

Vital-sign data were available from a time interval comparable with the hypoxia-event reference time or for up to 72 hours after admission to the general ward

Only one eligible data interval was included per patient

Oxygen-Treatment-Based Hypoxia-Positive Group

Hypoxia occurred in a general ward

Hypoxia was defined as oxygen administration at a flow rate of 4 L/min or more

Vital-sign data were available for up to 72 hours before the initiation of oxygen administration

If oxygen administration began within 24 hours after admission or transfer to the general ward, all available vital-sign data recorded before the event were included

If multiple eligible events occurred during the data collection period, only the first eligible event was included for this criterion

Oxygen-Treatment-Based Hypoxia-Negative Group

No hypoxia occurred during the selected general ward admission

Data were randomly selected from the same general wards as the corresponding hypoxia-positive group

Vital-sign data were available from a time interval comparable with the hypoxia-event reference time or for up to 72 hours after admission to the general ward

Only one eligible data interval was included per patient

Exclusion Criteria:

Hypoxia occurred outside a general ward

The patient had chronic obstructive pulmonary disease

A do-not-resuscitate order was in effect at the time the clinical data were recorded

The patient was pregnant or within 3 months after delivery at the time the clinical data were recorded

The data were considered inappropriate for the study by the principal investigator

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 2,250Actual
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

SpO2-Based Hypoxia-Positive Group

Adult general ward inpatient data meeting the SpO2-based hypoxia criterion, defined as oxygen saturation below 94% in the general ward. Vital-sign data collected for up to 72 hours before the first eligible hypoxia event were included. If the event occurred within 24 hours after admission or transfer to the general ward, all available vital-sign data recorded before the event were included. Only the first eligible event per patient was selected for this criterion.

SpO2-Based Hypoxia-Negative Group

Adult general ward inpatient data from patients who did not experience hypoxia during the selected general ward admission and that served as the comparator group for the SpO2-based analysis. Data were randomly selected from the same general wards as the positive group and from a time interval comparable with the hypoxia-event reference time or from up to 72 hours after admission to the general ward. Only one eligible data interval was selected per patient.

Oxygen-Treatment-Based Hypoxia-Positive Group

Adult general ward inpatient data meeting the oxygen-treatment-based hypoxia criterion, defined as administration of oxygen at a flow rate of 4 L/min or more in the general ward. Vital-sign data collected for up to 72 hours before the first eligible oxygen-treatment event were included. If the event occurred within 24 hours after admission or transfer to the general ward, all available vital-sign data recorded before the event were included. Only the first eligible event per patient was selected for this criterion.

Oxygen-Treatment-Based Hypoxia-Negative Group

Adult general ward inpatient data from patients who did not experience hypoxia during the selected general ward admission and that served as the comparator group for the oxygen-treatment-based analysis. Data were randomly selected from the same general wards as the positive group and from a time interval comparable with the hypoxia-event reference time or from up to 72 hours after admission to the general ward. Only one eligible data interval was selected per patient. The same negative datasets could also be used in the SpO2-based analysis.