Status:

COMPLETED

Dysphagia and VFMI in Cardiac Patients

Lead Sponsor:

University of Florida

Conditions:

Cardiac Disease

Eligibility:

All Genders

18-90 years

Brief Summary

The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing cardiothoracic surgical procedures. It also seeks to determine the ...

Detailed Description

Swallowing impairment and VFMI are common, yet often overlooked, complications of cardiac surgical procedures. The true incidence of both dysphagia and VFMI in this patient population is unclear due t...

Eligibility Criteria

Inclusion

  • adults aged 18 - 90 years old
  • undergoing planned or emergent cardiothoracic surgery via sternotomy and/or extended thoracotomy requiring cardiopulmonary bypass
  • willing to participate in post-operative swallowing evaluation testing

Exclusion

  • Patients undergoing exclusively transcatheter valves
  • Patients undergoing exclusively thoracic endovascular aortic repair procedures
  • The inability to achieve appropriate alertness and cognitive status following procedure will exclude one from completing the study.
  • Participants must pass cognition, respiratory and physical abilities screening to ensure testing safety.

Key Trial Info

Start Date :

February 3 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 2 2020

Estimated Enrollment :

207 Patients enrolled

Trial Details

Trial ID

NCT03768739

Start Date

February 3 2019

End Date

September 2 2020

Last Update

November 4 2020

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Cardiovascular Clinic at UF Health UF

Gainesville, Florida, United States, 32610

2

UF Health at the University of Florida

Gainesville, Florida, United States, 32610

3

Thoracic and Cardiovasscular Surgery at UF Health

Gainesville, Florida, United States, 32611