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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Noninvasive Cardiac Monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin L Ferguson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

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20110031

Identifier Type: -

Identifier Source: org_study_id