Monitoring Blood Flow and Breathing Using a New Device (RFII) Compared to the Gold Standard Device in Post Operative Cardiac Patients
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ClinicalTrials.gov Identifier: NCT01434771
(Sponsor never funded study.)
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.
Simultaneous Hemodynamic and Ventilatory Monitoring Using Radio Frequency Impedance Interrogation (RFII), Thoracic Impedance Cardiography and Invasive Hemodynamic Monitoring Methods in Post Operative Cardiac Patients
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients scheduled for open heart surgery
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
ECG lead adhesive allergy or sensitivity
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