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

This study has been withdrawn prior to enrollment.
(Sponsor never funded study.)
Sponsor:
Collaborators:
Noninvasive Medical Technologies, Inc.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01434771
First received: September 13, 2011
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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
Noninvasive Cardiac Monitoring

Study Type: Observational
Study Design: 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

Further study details as provided by University of Florida:

Enrollment: 0
Study Start Date: December 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients scheduled for open heart surgery

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434771

Sponsors and Collaborators
University of Florida
Noninvasive Medical Technologies, Inc.
Investigators
Principal Investigator: Kevin L Ferguson, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01434771     History of Changes
Other Study ID Numbers: 20110031
Study First Received: September 13, 2011
Last Updated: October 15, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 16, 2014