Clinical Markers of Dysphagia in Cardiac Surgical Patients

University of Florida

Status: Active, not recruiting

Conditions: Dysphagia; Cardiovascular Diseases

Treatments: Diagnostic Test: Videofluoroscopy instrumental swallowing exam (VFSS); Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing; Other: Reflex Cough Screen; Diagnostic Test: Speech Testing; Other: Voluntary Cough Peak Expiratory Flow (PEF) Testing; Other: Lingual Pressure Testing; Diagnostic Test: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05304416

R01NR020175 (U.S. NIH Grant/Contract)

IRB202200709

Details and patient eligibility

About

Although dysphagia is a known complication of cardiac surgery, risk factors and sensitive bedside clinical markers of dysphagia have not yet been identified. This longitudinal study will enroll 380 cardiac surgical patients and identify contributing risk factors of incident cases of dysphagia and identify sensitive bedside markers of dysphagia. Statistical modeling will produce two pragmatic clinical tools - a risk prediction model and a beside screening tool to improve care models.

Full description

Swallowing impairment and VFMI are common, yet often overlooked, complications of cardiovascular 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 patients undergoing cardiovascular surgery. The study is 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. In addition, the study is 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. The study will identify risk factors for postoperative dysphagia and VFMI in cardiovascular patients to build a practical electronic risk-stratification tool. The study will also aim to identify sensitive bedside clinical markers of dysphagia in postoperative cardiovascular patients to develop a bedside screening tool. All participants with planned surgeries will undergo two research visits (one preoperatively and one postoperatively) where they will undergo an instrumental swallowing test and complete several patient report outcomes and clinical tests. If they are found to have dysphagia after surgery, they will be offered no-cost follow-up swallow tests at months 1 and 6. For those without planned surgeries, the same course of tests with the exception of the preoperative research visit will be completed. Finally, health-related outcomes will be indexed in enrolled participants to determine the impact of dysphagia.

Enrollment: 347 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals 18-90 years of age
• Undergoing planned or emergent cardiothoracic surgery via sternotomy and/or extended thoracotomy at the University of Florida Heart and Vascular Hospital
• Not pregnant
• Willing to participate in research exams.

Exclusion criteria

• Pregnant women
• Those unwilling to participate in research exams.

Trial design

347 participants in 2 patient groups

Cardiovascular Surgical Patients Preoperative Exam

Description:

All enrolled participants will undergo a baseline Fiberoptic Endoscopic Evaluation of Swallowing (FEES) or a Simultaneous FEES and Videofluoroscopy instrumental swallowing exam before their surgery to determine baseline / preoperative swallowing function. Those with confirmed dysphagia will not be asked to complete the postoperative swallowing exam, given our desire to examine contributing risk factors for dysphagia development and mechanisms within cardiovascular surgical patients. In addition to the instrumental exam, systematic collection of demographic, medical, surgical, and intubation-related candidate predictor variables will be conducted over the entire perioperative period.

Treatment:

Diagnostic Test: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam

Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing

Diagnostic Test: Videofluoroscopy instrumental swallowing exam (VFSS)

Cardiovascular Surgical Patients Postoperative Exam

Description:

Participants without preoperative dysphagia will be seen for a postop exam within 72 hours of extubation. Simultaneous imaging using FEES and videofluoroscopy (or a FEES or VFSS exam in isolation) will be performed at the bedside, as well as a battery of clinical tests. Completion of these postoperative tests will indicate study completion for participants without evidence of dysphagia, while participants who demonstrate acute-phase postoperative dysphagia will continue to participate if they desire. During their standard of care one-month follow-up appointment, a third research evaluation will be offered for participants with previously identified postoperative dysphagia. During this exam, the same imaging and clinical tests from the previous research exam will be performed. Finally, participants with persisting dysphagia will be offered the opportunity to continue to be studied for a fourth and final research exam during their standard of care six-month follow-up clinic visit.

Treatment:

Diagnostic Test: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam

Other: Lingual Pressure Testing

Diagnostic Test: Speech Testing

Other: Voluntary Cough Peak Expiratory Flow (PEF) Testing

Other: Reflex Cough Screen

Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing

Diagnostic Test: Videofluoroscopy instrumental swallowing exam (VFSS)