Clinical Markers of Dysphagia in Cardiac Surgical Patients

October 10, 2025 updated by: University of Florida

Mechanisms, Predictors & Clinical Markers of Dysphagia in Cardiac Surgical Patients_R01

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

347

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Ohio
      • Columbus, Ohio, United States, 43212
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Up to 380 patients being seen at the University of Florida (UF) Heart and Vascular Hospital (HVN) will make up the local convenience sample of eligible CS patients for this study.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiovascular Surgical Patients Preoperative Exam
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.
Diagnostic test: Fiberoptic Endoscopic Evaluation of Swallowing
This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.
Other Names:
  • FEES
Diagnostic test: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam
This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism. The participant will be asked to perform some voicing tasks, once completed, a videofluoroscopic swallowing exam will occur at the same time. This is like a moving x-ray of the participant swallowing foods and liquids (barium).
Other Names:
  • Endofluoroscopy
Diagnostic test: Videofluoroscopy instrumental swallowing exam (VFSS)
This is like a moving x-ray of the participant swallowing foods and liquids (barium).
Other Names:
  • Modified barium swallow study
Cardiovascular Surgical Patients Postoperative Exam
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.
Diagnostic test: Fiberoptic Endoscopic Evaluation of Swallowing
This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.
Other Names:
  • FEES
Diagnostic test: Simultaneous FEES and Videofluoroscopy instrumental swallowing exam
This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism. The participant will be asked to perform some voicing tasks, once completed, a videofluoroscopic swallowing exam will occur at the same time. This is like a moving x-ray of the participant swallowing foods and liquids (barium).
Other Names:
  • Endofluoroscopy
Diagnostic test: Videofluoroscopy instrumental swallowing exam (VFSS)
This is like a moving x-ray of the participant swallowing foods and liquids (barium).
Other Names:
  • Modified barium swallow study
Other: Voluntary Cough Peak Expiratory Flow (PEF) Testing
Cough PEF will be performed to index a participant's physiologic airway defense capacity and strength. Testing will occur with the participant seated upright at 90 degrees using an analog peak flow meter with a one-way expiratory valve that prevents a participant from breathing air in from the device to reduce contamination.
Other: Reflex Cough Screen
Participants will be seated upright and administered reflex cough testing via a disposable adult aerosol mask with an attached nebulizer that contains a solution to elicit a cough response.
Other: Lingual Pressure Testing
Lingual strength will be evaluated using the Iowa Oral Pressure Instrument (IOPI). Participants will be seated upright, and the SLP will place the IOPI air-filled sensing bulb in the midline anterior position on the participant's tongue, posterior to the alveolar ridge.
Diagnostic test: Speech Testing
Speech assessment will occur with the participant comfortably seated headset microphone with a lapel windscreen connected to a TASCAM DR40 to allow for high-quality audio recordings. Individuals will be asked to perform two maximal performance speech tasks that include vowel prolongation of /a/, and a Diadochokinetic (DDK) rate task to examine SMR for production of the word "buttercup."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penetration Aspiration Scale
Time Frame: Baseline (Prior to surgery)
This scale is a validated measure used by trained blinded clinicians to assign ratings of safety to swallowing bolus trials. The development and use of an 8-point, equal-appearing interval scale (8 being best; 1 being worst) to describe penetration and aspiration events are described. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. (Simultaneous or FEES exam)
Baseline (Prior to surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penetration Aspiration Scale
Time Frame: Follow-up - Within 72 hours following extubation from surgery and onward
This scale is a validated measure used by trained blinded clinicians to assign ratings of safety to swallowing bolus trials. The development and use of an 8-point, equal-appearing interval scale (8 being best; 1 being worst) to describe penetration and aspiration events are described. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. (Used in Simultaneous, FEES, or VFSS)
Follow-up - Within 72 hours following extubation from surgery and onward

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute of Nursing Research (NINR)
Ohio State University

Investigators

  • Principal Investigator: Eric I Jeng, MD, MBA, University of Florida

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 Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Estimated)

October 14, 2025

Last Update Submitted That Met QC Criteria

October 10, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202200709
  • R01NR020175 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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