Dysphagia in Cardiac Surgical Patients

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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.

Conditions:

🦠 Cardiovascular Diseases 🦠 Dysphagia

🗓️ Study Start (Actual) 7 June 2022

🗓️ Primary Completion (Estimated) 1 October 2026

✅ Study Completion (Estimated) 31 December 2026

👥 Enrollment (Estimated) 380

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Gainesville, Florida, United States

📍 Columbus, Ohio, United States

📋 Eligibility Criteria

Description

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.

Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 21 March 2022
First Submitted that Met QC Criteria 22 March 2022
First Posted 31 March 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 20 December 2023
Last Update Posted 27 December 2023
Last Verified December 2023