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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01434771
Recruitment Status : Withdrawn (Sponsor never funded study.)
First Posted : September 15, 2011
Last Update Posted : October 16, 2013
Noninvasive Medical Technologies, Inc.
United States Department of Defense
Information provided by (Responsible Party):
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.

Condition or disease
Noninvasive Cardiac Monitoring

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Simultaneous Hemodynamic and Ventilatory Monitoring Using Radio Frequency Impedance Interrogation (RFII), Thoracic Impedance Cardiography and Invasive Hemodynamic Monitoring Methods in Post Operative Cardiac Patients
Study Start Date : December 2012
Primary Completion Date : December 2012
Study Completion Date : December 2012

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for open heart surgery

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01434771

Sponsors and Collaborators
University of Florida
Noninvasive Medical Technologies, Inc.
United States Department of Defense
Principal Investigator: Kevin L Ferguson, MD University of Florida

Responsible Party: University of Florida Identifier: NCT01434771     History of Changes
Other Study ID Numbers: 20110031
First Posted: September 15, 2011    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013