The Use of Master Caution System for Continuous Monitoring and Detection of Dysrhythmia and Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Measuring 12 leads ECG information of patients at the ICCU in continuous monitoring using Master Caution System (MCS) will give more cardiac information comparing to regular hospital 2-3 leads telemetry.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.
The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test.
The purpose of the study is to reassess the adequate size of the Master Caution Garment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years.
- •Diagnosed or have evidence of ACS, or referred for stress imaging due to suspected ischemia with STT changes.
- •Needs continuous/routine ECG monitoring.
- •Ability to give informed consent.
- •Cooperative person
排除标准
- •Patients with known allergy to silver.
- •Patients with dermal disease or recent trauma to the chest wall.
- •Pregnant or lactating woman.
- •Patients with chest deformity precluding placement of the garment.
- •Patients suffering from tremor.
- •Patients participating in another ongoing trial.
结局指标
主要结局
Measuring 12 leads ECG information of patients at the ICCU in continuous monitoring using Master Caution System (MCS) will give more cardiac information comparing to regular hospital 2-3 leads telemetry.
时间窗: 48 hours
Measuring 12 leads ECG information of patients at the stress test using Master Caution System (MCS) comparing to the standard of care stress test ECG device and Electrodes.
时间窗: 1-2 hours
次要结局
- Master Caution System (MCS) cardiac telemetry system will measure and provide sufficient ECG information for adequate detection and interpretation of ST-T wave changes and dysrhythmic events.(during the use of the system)