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Prospective Study to Evaluate the Clinical Effectiveness of 'AITRICS-VC(MORS),' an AI Software for Predicting the Risk of Mortality in ICU Patients.

Multi-center, Pre and Post Comparative, Observational Study to Evaluate the Clinical Effectiveness of 'AITRICS-VC(MORS),' an AI-Based Biosignal Analysis Software for Predicting the Risk of Mortality in ICU Patients Using EMR Data.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009877
Enrollment
11368
Registered
2024-10-25
Start date
2024-09-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Aitrics
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 years or older, both male and female. 2) For the case group, patients who have been admitted to or had a stay in the ICU at the clinical trial site within 9 months from the study initiation date, following IRB approval. 3) For the control group, patients who have been admitted to or had a stay in the ICU at the clinical trial site within 9 months from two years prior to the study initiation date, following IRB approval.

Exclusion criteria

Exclusion criteria: 1) Patients without records of admission to or stay in the ICU. Additional Exclusion Criteria (Post-Clinical Data Collection): 1) During the ICU stay, if any of the five vital signs(systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature) are missing at least one recorded measurement, resulting in the failure to generate a device performance outcome. 2) If the occurrence time information for death or CPR events is not collected in cases where these events have occurred. 3) If there are discrepancies in the recorded EMR data, such as missing ICU stay records or errors in admission and discharge records. 4) Individuals aged 18 years or younger.

Design outcomes

Primary

MeasureTime frame
Overall ICU mortality rates;CPR administration rates

Secondary

MeasureTime frame
Short-term mortality: 1-day, 3-day, 7-day mortality and 28-days cumulative mortality;Endotracheal intubation rates, duration of ventilator use (hr), and prediction lead time;Rate of continuous renal replacement therapy(CRRT) administration, duration of CRRT (hr), and prediction lead time;Vasopressor administration rates, duration of vasopressor use and prediction lead time;Proportion of patients who improved after ICU care (i.e., those who were transferred from the ICU to a general ward and did not readmit to the ICU within 48 hours);Rate of transfer from the ICU to the general ward;Rate of ICU readmission within 48 hours;Average length of stay in the ICU;Costs of ICU treatment for patients transferred to a general ward versus those discharged after improvement;Mortality prediction accuracy of MORS and prediction lead time;Subgroup analysis of MORS by diagnosis among ICU admission patients.;Correlation analysis between AITRICS-VC MAES and SEPS scores, medical scores MEWS and NEWS obtained just prior to ICU admission, and MORS following ICU admission.;Comparison of mortality prediction accuracy at the time of ICU admission for MORS, APACHE II, SOFA, and SAPS3 scores

Countries

Korea, Republic of

Contacts

Public ContactSeung Min Baik

Ewha Womans University Medical Center

illaillailla@naver.com+82-2-2650-5114

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 23, 2026