Introductory Non-Clinical and Clinical Trial for Measuring Hydration Levels of Healthy and Heart Failure Patients Before, During, and After an Electrophysiology (EP) Procedure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- NYU Langone Health
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- changes in body water content before, during and after an Electrophysiology Procedure
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
changes in body water content before, during and after an Electrophysiology Procedure
Time Frame: 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.