Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE)

Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE) Prompts Immediate Treatment

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.

Study Overview

• Status: Completed
• Conditions: Hypokalemia; Hyperkalemia
• Intervention / Treatment: Other: Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system

• Study Type: Interventional
• Enrollment (Actual): 14989
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • National defense medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients randomized to intervention will be cared by physicians under AI-ECG support.	Other: Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system; Once the AIDE indicates high risk of dyskalemia, an obvious message by scarlet letter was appeared in the HIS operation interface to corresponding physicians. To avoid the alert fatigue, we selected the cut-off points with expected positive predictive values of ≥40% according to previous data, which was the consensus of enrolled physicians before the trial considering the clinical loading. The physicians received the AIDE alerts as long as they were operating HIS logged in by their account, even if they were caring other patients. Physicians can review the AIDE predictions of patients in the intervention group. Therefore, this was a single-blind study since HIS presented different information for patients in intervention and control groups. The participated physicians understood the likelihood of dyskalemia and cardiac risk for those patients with ECG-dyskalemia, and provided suitable medical care according to patients' conditions.
No Intervention: Control; Patients randomized to control will be cared by routine practice.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyperkalemia; Hypokalemia
• Other Study ID Numbers: NDMC2021004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No