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

University of Florida

Status: Withdrawn

Conditions: Noninvasive Cardiac Monitoring

Study type: Observational

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT01434771

20110031

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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