Dysphagia and VFMI in Cardiac Patients

University of Florida

Status: Completed

Conditions: Cardiac Disease

Treatments: Procedure: Fiberoptic Endoscopic Evaluation of Swallowing

Study type: Observational

Funder types: Other

Identifiers

NCT03768739

IRB201802740

Details and patient eligibility

About

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 impact of postoperative swallowing impairment on health-related outcomes.

Full 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 to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patents undergoing cardiac surgery. We therefore aimed to determine the incidence of dysphagia and VFMI in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. We also aimed to assess the relative impact of VFMI and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status.

Enrollment: 207 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

207 participants in 1 patient group

CICU extubated patients

Description:

Participants will undergo a Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

Treatment:

Procedure: Fiberoptic Endoscopic Evaluation of Swallowing