Dysphagia in Cardiac Surgical Patients_

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University of Florida

Status

Withdrawn

Conditions

Cardiovascular Diseases

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT04496986
OCR39324 (Other Identifier)
IRB202001367

Details and patient eligibility

About

The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing cardiovascular 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 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. We will identify risk factors for postoperative dysphagia and VFMI in cardiovascular patients to build a practical electronic risk-stratification tool. We also aim to identify sensitive bedside clinical markers of dysphagia in postoperative cardiovascular patients to develop a bedside screening tool. All participants 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. Finally, health-related outcomes will be indexed in enrolled participants to determine the impact of dysphagia.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: 1) individuals over 18 years of age, 2) undergoing a cardiovascular procedure at the University of Florida Heart and Vascular Hospital, 3) confirmed negative COVID-19 test result, 4) no allergies to barium, 5) not pregnant (female participants), and 6) willing to participate in research exams.

Exclusion Criteria: 1) individuals under the age of 18, 2) patients with a confirmed positive COVID-19 test result, 3) participants with allergies to barium, 4) pregnant women, or 5) unwilling to participate in research exams.

Trial design

0 participants in 2 patient groups

Cardiovascular Surgical Patients Preoperative Exam
Description:
All enrolled participants will undergo a baseline Fiberoptic Endoscopic Evaluation of Swallowing (FEES) 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: Fiberoptic Endoscopic Evaluation of Swallowing
Cardiovascular Surgical Patients Postoperative Exam
Description:
All remaining participants without preoperative dysphagia will be seen for a postoperative exam performed within 48 hours of extubation. Simultaneous imaging using FEES and videofluoroscopy 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: Fiberoptic Endoscopic Evaluation of Swallowing
Other: Voluntary Cough Peak Expiratory Flow (PEF) Testing
Other: Reflex Cough Screen
Diagnostic Test: Speech Testing
Other: Lingual Pressure Testing
Diagnostic Test: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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