Introductory Non-Clinical and Clinical Trial for Measuring Hydration Levels of Healthy and Heart Failure Patients Before, During, and After an Electrophysiology (EP) Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- changes in body water content before, during and after an Electrophysiology Procedure
研究概览
简要总结
Subjects will be consented to wear the AleriTM sensor prior to, during, and after an Electrophysiology Procedure. During this time, the system will measure the following parameters from subjects: HR, temperature, saline volume/rate, urine production volume, USG, BPO. Data will be retrospectively analyzed to determine if the system effectively operates under these conditions, and can effectively monitor hydration levels of subjects compared to currently available methods.
详细描述
Study subjects scheduled for an EP procedure who have signed an informed consent form (ICF) will be admitted to the study. Prior to the EP procedure (e.g. in a hospital room or operating room at NYU Medical Center), either an employee of NYU or Hydrostasis will place sensor on subject's bicep, forearm, or wrist, start the sensor and connect the sensor to mobile app to start data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cardiac arrhythmias or other cardiac conditions that are scheduled for EP procedures.
- •Subject is over 18 years of age at the time of consenting
- •Subject and/or legally authorized representative is willing to undergo the informed consent process prior to enrollment in the study
排除标准
- •Pregnant subjects
- •Subjects who are participating in another clinical study that may affect the results of either study
- •Subjects who are unwilling or unable to wear the sensor for a period of up to 14 hours
- •Subjects who are considered by the principle investigator to be medically unsuitable for study participation
结局指标
主要结局
changes in body water content before, during and after an Electrophysiology Procedure
时间窗: 1 hour pre-surgery, during surgery and 3-5 hours post-surgery
Study team will compare the hydration status (changes in body water content) as predicted by the Aleri sensor to changes in volume according to the routinely reported volume exchanges. This will be a correlation study, and as such the purpose would be to use Pearsons' correlation between the device measurement and the interval changes in fluids ingested or excreted by the patient. There is no benchmark, but rather we will be looking for statistically significant correlation for any r\>.5.
次要结局
未报告次要终点