Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (Intrepid Clinical Engineering) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Validation of Algorithm Software Update
研究概览
简要总结
The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.
详细描述
The purpose of this study is to validate the Philips DXL electrocardiogram Algorithm works as intended in the HeartStart Intrepid Monitor/Defibrillator after a software update was completed to address instances of high impedance. This study will also determine the diagnostic quality of the 12-lead electrocardiogram tracing from the HeartStart Intrepid Monitor/Defibrillator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The qualified electrocardiogram reviewer will be blinded to the age of electrodes
入排标准
- 年龄范围
- 29 Days 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to read, write, speak, and understand English
- •Age: 29 days to 89 years
- •Willing and able to provide informed consent and complete study procedures
- •Willing to have Philips representatives present during study procedures.
排除标准
- •Known allergy to medical adhesives, silicone, or latex (per self-report)
- •Any limitation or medical condition, including but not limited to physical or cognitive disability, that would affect the participant's ability to complete study activities (per investigator)
- •At the time of enrollment, current enrollment in any other interventional research study
- •An employee, or residing family member of an employee, of a company that designs, sells, or manufactures monitor/defibrillator technology or related products (including Philips)
研究组 & 干预措施
New electrodes
New package of electrodes
干预措施: 12 lead Electrocardiogram (Diagnostic Test)
24-hour opened electrodes
Electrodes opened 24 hours
干预措施: 12 lead Electrocardiogram (Diagnostic Test)
30 day opened electrodes
Electrodes opened 30 days
干预措施: 12 lead Electrocardiogram (Diagnostic Test)
结局指标
主要结局
Validation of Algorithm Software Update
时间窗: day 1
Number of participants with failure to obtain a 12-lead Electrocardiogram (ECG) with the Philips HeartStart Intrepid Monitor/Defibrillator.
Diagnostic Quality
时间窗: day 1
Number of participants with diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid Monitor/Defibrillator.
次要结局
- Adverse Events(day 1)
- Unanticipated Adverse Device Effects (UADE)(day 1)