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Clinical Trials/NCT05118022
NCT05118022CompletedNot Applicable

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

National Defense Medical Center, Taiwan2 sites in 1 country14,989 target enrollmentStarted: January 1, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
14,989
Locations
2
Primary Endpoint
Cumulative proportion of hyperkalemia treatment
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Cumulative proportion of hyperkalemia treatment

Time Frame: Within 3 hours

Calcium supplement, insulin, potassium binding resin, β2-agonist, loop diuretics, sodium bicarbonate, and hemodialysis.

Cumulative proportion of hypokalemia treatment

Time Frame: Within 3 hours

Intravenous potassium chloride, oral potassium gluconate, and oral potassium chloride

Secondary Outcomes

  • Cardiac arrest (sudden death)(Within 3 days)
  • Cumulative proportion of All-cause mortality(Within 365 days)
  • Cumulative proportion of electric shock(Within 6 hours)
  • Cumulative proportion of CPR event(Within 6 hours)
  • Cumulative proportion of Discharge(Within 14 days)
  • Cumulative proportion of Treatment-induced hypokalemia event(Within 24 hours)
  • Cumulative proportion of Treatment-induced hyperkalemia event(Within 24 hours)

Investigators

Sponsor
National Defense Medical Center, Taiwan
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chin Lin

Associate Professor

National Defense Medical Center, Taiwan

Study Sites (2)

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