Applying an Artificial Intelligence-Enabled Electrocardiographic System for Reducing Mortality

National Defense Medical Center, Taiwan

Status: Completed

Conditions: Morality; Cardiovascular Diseases; Intensity Care

Treatments: Other: AI-enabled ECG-based Screening Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT05118035

NDMC2021005

Details and patient eligibility

About

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for early detection of clinical deterioration for reducing mortality.

Enrollment: 15,965 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in emergency department or inpatient department.
• Patients recieved at least 1 ECG examination.

Exclusion criteria

• The patients recieved ECG at the period of inactive AI-ECG system.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15,965 participants in 2 patient groups

Intervention

Experimental group

Description:

Patients randomized to intervention will have access to the screening tool. Once the AI-ECG indicates high risk of mortality, a warning message would be immediately triggered and sent to the corresponding attending physicians. Notifications appear in the recipient's smartphone message system for the prompt attention. The message notified the physician that, "An ECG was received for patient X. An ECG indicates high risk of mortality. Please intensively attend to patient's conditions. If the physicians need to further identify the ECG, click on the following link to connect the ECG and the result of AI-ECG prediction." Of note, although we will actively send a warning message for high risk cases, the AI-ECG report for low risk cases still presented the degree of risk. Physicians can check the relative severity by access EHR for patients in the intervention group.

Treatment:

Other: AI-enabled ECG-based Screening Tool

Control

No Intervention group

Description:

Patients will continue routine practice.