Study Stopped
Sponsor never funded study.
Monitoring Blood Flow and Breathing Using a New Device (RFII) Compared to the Gold Standard Device in Post Operative Cardiac Patients
Simultaneous Hemodynamic and Ventilatory Monitoring Using Radio Frequency Impedance Interrogation (RFII), Thoracic Impedance Cardiography and Invasive Hemodynamic Monitoring Methods in Post Operative Cardiac Patients
1 other identifier
observational
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2011
CompletedFirst Posted
Study publicly available on registry
September 15, 2011
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 16, 2013
October 1, 2013
Same day
September 13, 2011
October 15, 2013
Conditions
Eligibility Criteria
Patients scheduled for open heart surgery
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Noninvasive Medical Technologies, Inc.collaborator
- United States Department of Defensecollaborator
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin L Ferguson, MD
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2011
First Posted
September 15, 2011
Study Start
December 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 16, 2013
Record last verified: 2013-10