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

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.

Study Overview

• Status: Withdrawn
• Conditions: Noninvasive Cardiac Monitoring

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for open heart surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: United States Department of Defense; Noninvasive Medical Technologies, Inc.
• Investigators: Principal Investigator: Kevin L Ferguson, MD, University of Florida

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 14, 2011
• First Posted (Estimate): September 15, 2011

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 15, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 20110031

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No