Status:
WITHDRAWN
Monitoring Blood Flow and Breathing Using a New Device (RFII) Compared to the Gold Standard Device in Post Operative Cardiac Patients
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Noninvasive Medical Technologies, Inc.
United States Department of Defense
Conditions:
Noninvasive Cardiac Monitoring
Eligibility:
All Genders
18+ years
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 Medica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01434771
Start Date
December 1 2012
End Date
December 1 2012
Last Update
October 16 2013
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