Clinical Markers of Dysphagia in Cardiac Surgical Patients
Mechanisms, Predictors & Clinical Markers of Dysphagia in Cardiac Surgical Patients_R01
2 other identifiers
observational
347
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
June 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 14, 2025
October 1, 2025
4.3 years
March 21, 2022
October 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Penetration Aspiration Scale
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 Outcomes (1)
Penetration Aspiration Scale
Follow-up - Within 72 hours following extubation from surgery and onward
Study Arms (2)
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.
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.
Interventions
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.
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).
This is like a moving x-ray of the participant swallowing foods and liquids (barium).
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.
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.
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.
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."
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Pregnant women
- Those unwilling to participate in research exams.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- National Institute of Nursing Research (NINR)collaborator
- Ohio State Universitycollaborator
Study Sites (2)
University of Florida
Gainesville, Florida, 32610, United States
The Ohio State University
Columbus, Ohio, 43212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric I Jeng, MD, MBA
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2022
First Posted
March 31, 2022
Study Start
June 7, 2022
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share