NCT05441852已完成不适用
Rapid dEtection of HyperkAlemia (K+) in the EmergenCy Department Using a SmarTphone-enabled Single-lead EKG (REACT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1,151
- 试验地点
- 1
- 主要终点
- Hyperkalemia detection by AI enhanced ECG
研究概览
简要总结
The purpose of this study is to validate the real-world performance of a previously developed Artificial Intelligence - Electrocardiogram (AI-ECG) algorithm for identification of hyperkalemia with a six-lead mobile-enhanced device .
详细描述
- Ambulatory adult patients in the Emergency Department (ED) at increased risk for hyperkalemia (due to age ≥ 50 years, and one or more criteria including estimated Glomerular filtration rate (eGFR) (from serum creatinine) < 45 ml/minute and/or a history of serum potassium > 5.2 milliequivalents per liter (mEq/l) who present to the emergency department will be approached to consent for the rapid screening process.
- Those who consent will undergo 30 second 6 L ECG recording with a portable, mobile-enhanced device (AliveCor Kardia).
- This ECG data is subsequently evaluated by our artificial intelligence algorithm to detect hyperkalemia, and the estimated probability of hyperkalemia is recorded.
- The research team notifies supervising Emergency Department staff of patients whose probability of hyperkalemia is significantly elevated above the optimized cutoff point according to the AI-ECG algorithm.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than/equal to 50 years and able to provide consent.
- •Patients with eGFR (from serum creatinine) < 45 ml/minute and/or a history of serum potassium > 5.2 mEq/l.
排除标准
- •Patients underage <
- •Do not meet inclusion criteria.
- •Unstable patients requiring emergent resuscitation.
- •Patients unable to provide consent.
结局指标
主要结局
Hyperkalemia detection by AI enhanced ECG
时间窗: 12 months
Understanding model's ability to predict hyperkalemia as determined by the area under the receiver operating characteristic
次要结局
- Performance metrics for the detection of hyperkalemia by AI enhanced ECG(12 months)
研究者
研究点 (1)
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