Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE)

Not Applicable

Completed

• Conditions: Hypokalemia; Hyperkalemia
• Interventions: Other: Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system

• Registration Number: NCT05118022
• 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 improving the diagnosis and management of potassium abnormalities.

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: 2022-01-01
• Primary Completion: 2022-10-31
• Study Completion: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14989

Inclusion Criteria

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

Exclusion Criteria

• Patients recieved dyskalemia-related treatment before ECG examination.
• 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	Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system	Patients randomized to intervention will be cared by physicians under AI-ECG support.

Primary Outcome Measures

Name	Time	Method
Cumulative proportion of hyperkalemia treatment	Within 3 hours	Calcium supplement, insulin, potassium binding resin, β2-agonist, loop diuretics, sodium bicarbonate, and hemodialysis.
Cumulative proportion of hypokalemia treatment	Within 3 hours	Intravenous potassium chloride, oral potassium gluconate, and oral potassium chloride

Secondary Outcome Measures

Name	Time	Method
Cardiac arrest (sudden death)	Within 3 days	Cardiac arrest (sudden death)
Cumulative proportion of All-cause mortality	Within 365 days	All-cause mortality
Cumulative proportion of electric shock	Within 6 hours	Cardioversion
Cumulative proportion of CPR event	Within 6 hours	Cardiopulmonary pesuscitation
Cumulative proportion of Discharge	Within 14 days	Discharge from inpatient department or emergency department
Cumulative proportion of Treatment-induced hypokalemia event	Within 24 hours	Treatment-induced hypokalemia event
Cumulative proportion of Treatment-induced hyperkalemia event	Within 24 hours	Treatment-induced hyperkalemia event

Trial Locations

Locations (1)

National Defense Medical Center; 🇨🇳 Taipei, Taiwan