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

NCT07742813 | Completed

• 1 other identifier: HA-PI-01
• Study Type: observational
• Target: 2,250
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Keywords

Hypoxia Prediction; Hypoxemia; Vital-PICASO; Artificial Intelligence; Biological Signal Analysis Software; Vital Signs; General Ward Inpatients; Oxygen Saturation; Oxygen Therapy; Early Warning System; Clinical Decision Support

Outcome Measures

Primary Outcomes (2)

• Area Under the Receiver Operating Characteristic Curve for SpO2-Based Hypoxia Prediction

  The area under the receiver operating characteristic curve (AUROC) is calculated by comparing the hypoxia risk scores generated by Vital-PICASO with the reference-standard classification for the SpO2-based analysis. Hypoxia-positive cases are defined as cases in which oxygen saturation below 94% occurred in the general ward. Hypoxia-negative cases are selected from patients who did not experience hypoxia during the corresponding general ward admission period. AUROC ranges from 0 to 1, with a higher value indicating better discrimination between hypoxia-positive and hypoxia-negative cases. The prespecified success criterion is met if the lower bound of the 95% confidence interval for the difference between the Vital-PICASO AUROC and the comparator AUROC of 0.7891 is greater than 0.

  Within 24 hours before the SpO2-based hypoxia event or during the corresponding reference period for negative cases

• Area Under the Receiver Operating Characteristic Curve for Oxygen-Treatment-Based Hypoxia Prediction

  The area under the receiver operating characteristic curve (AUROC) is calculated by comparing the hypoxia risk scores generated by Vital-PICASO with the reference-standard classification for the oxygen-treatment-based analysis. Hypoxia-positive cases are defined as cases in which oxygen was administered at a flow rate of 4 L/min or more in the general ward. Hypoxia-negative cases are selected from patients who did not experience hypoxia during the corresponding general ward admission period. AUROC ranges from 0 to 1, with a higher value indicating better discrimination between hypoxia-positive and hypoxia-negative cases. The prespecified success criterion is met if the lower bound of the 95% confidence interval for the difference between the Vital-PICASO AUROC and the comparator AUROC of 0.7891 is greater than 0.

  Within 24 hours before oxygen administration at 4 L/min or more or during the corresponding reference period for negative cases

Secondary Outcomes (6)

• Area Under the Precision-Recall Curve for SpO2-Based Hypoxia Prediction

  Within 24 hours before the SpO2-based hypoxia event or during the corresponding reference period for negative cases

• Area Under the Precision-Recall Curve for Oxygen-Treatment-Based Hypoxia Prediction

  Within 24 hours before oxygen administration at 4 L/min or more or during the corresponding reference period for negative cases

• Precision, Recall, and F1 Score Across Risk-Score Thresholds

  Within the 24-hour prediction window before the hypoxia event or corresponding reference period

• Predictive Performance by Prediction-Time Interval

  At prespecified time intervals within 24 hours before the hypoxia event or corresponding reference time point

• Predictive Performance by Cumulative Prediction Window

  Over cumulative prediction windows of up to 24 hours before the hypoxia event or corresponding reference time point

Study Arms (4)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of male and female patients aged 19 years or older who were admitted to a general ward at Seoul National University Hospital for at least 12 hours and had electronic medical record data available between January 1, 2023, and May 31, 2025. The retrospective study datasets include hypoxia-positive and hypoxia-negative cases evaluated separately according to two reference-standard criteria: oxygen saturation below 94% and oxygen administration at a flow rate of 4 L/min or more.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huinno AIM: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: August 20, 2025
• Primary Completion: June 12, 2026
• Study Completion: July 7, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)