Applying an Artificial Intelligence-Enabled Electrocardiographic System for Reducing Mortality

Not Applicable

Completed

• Conditions: Intensity Care; Cardiovascular Diseases; Morality
• Interventions: Other: AI-enabled ECG-based Screening Tool

• Registration Number: NCT05118035
• Lead Sponsor: National Defense Medical Center, Taiwan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-11
• Study Start: 2021-12-15
• Primary Completion: 2022-04-30
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15965

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	AI-enabled ECG-based Screening Tool	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.

Primary Outcome Measures

Name	Time	Method
All cause mortality (death)	Within 90 days	After performing an electrocardiogram, the patient's survival is tracked.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular cause mortality (death)	Within 90 days	After performing an electrocardiogram, the patient's survival is tracked.
Arrhythmia medication	Within 12 hours	After performing an electrocardiogram, the patient recieved related intervention.
Electrolyte examination	Within 3 days	After performing an electrocardiogram, the patient recieved electrolyte examination
Cadiac examination	Within 3-7 days	After performing an electrocardiogram, the patient recieved cadiac examination

Trial Locations

Locations (1)

National Defense Medical Center; 🇨🇳 Taipei, Taiwan