Monitoring Blood Flow and Breathing Using a New Device (RFII) Compared to the Gold Standard Device in Post Operative Cardiac Patients

University of Florida

Overview

The purpose of this study will be to compare standard of care invasive methods to an FDA approved non-invasive device and a novel wireless non-invasive device, both manufactured by Non-Invasive Medical Technologies Inc., with the goal of correlating the data generated by the novel device to the measurements taken by the standard of care invasive monitors.

Study Type

OBSERVATIONAL

Conditions

Noninvasive Cardiac Monitoring

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years and older * Weight - 36-136 Kilograms * Height - 1.52 meters - 1.92 meters (5'- 6'4") * Scheduled for open heart surgery during the study period Exclusion Criteria: * ECG lead adhesive allergy or sensitivity * Pregnant Patients * Prisoners * Cognitively impaired * Patients requiring mechanical cardiac support, or requirement for hemodialysis * Patients not requiring pulmonary artery catheters for medical management. * Patients with significant valvular disease will be enrolled if there is no significant post-repair valvular dysfunction as determined by intraoperative transesophageal echocardiography

Data from ClinicalTrials.gov

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