Hyperkalemia, Hypokalemia
Conditions
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.
Interventions
OTHERArtificial 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.
Sponsors
National Defense Medical Center, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cumulative proportion of electric shock | Within 6 hours | Cardioversion |
| Cumulative proportion of CPR event | Within 6 hours | Cardiopulmonary pesuscitation |
| Cardiac arrest (sudden death) | Within 3 days | Cardiac arrest (sudden death) |
| 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 |
| Cumulative proportion of Discharge | Within 14 days | Discharge from inpatient department or emergency department |
| Cumulative proportion of All-cause mortality | Within 365 days | All-cause mortality |
Countries
Taiwan
Outcome results
None listed