Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE)

Study Overview
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Brief Summary
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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.

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

Conditions
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Hyperkalemia, Hypokalemia

Intervention / Treatment
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* Other: Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients randomized to intervention will be cared by physicians under AI-ECG support. | Other: Artificial Intelligence identified Dyskalemia using Electrocardiogram (AIDE) system<br>* 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.<br>|
| No Intervention: Control<br>Patients randomized to control will be cared by routine practice. | |

What is the study measuring?
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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 | 
| Cumulative proportion of echocardiogram | Echocardiogram for patients with abnormal ECG. | Within 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative proportion of ICU admission | ICU admission | Within 3 days | 
| Cumulative proportion of Discharge | Discharge from inpatient department or emergency department | Within 14 days | 
| Cumulative proportion of ED revisits in patients without hospitalization | ED revisits in patients without hospitalization | Within 30 days |