Monitoring Blood Flow and Breathing Using a New Device (RFII) Compared to the Gold Standard Device in Post Operative Cardiac Patients
Withdrawn
- Conditions
- Noninvasive Cardiac Monitoring
- Registration Number
- NCT01434771
- Lead Sponsor
- University of Florida
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method