Clinical Markers of Dysphagia in Cardiac Surgical Patients
NCT05304416 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 347
Last updated 2025-10-14
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.
Conditions
Interventions
- 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.
- 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).
- DIAGNOSTIC_TEST
-
Videofluoroscopy instrumental swallowing exam (VFSS)
This is like a moving x-ray of the participant swallowing foods and liquids (barium).
- 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."
Sponsors & Collaborators
-
National Institute of Nursing Research (NINR)
collaborator NIH -
Ohio State University
collaborator OTHER -
University of Florida
lead OTHER
Principal Investigators
-
Eric I Jeng, MD, MBA · University of Florida
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-07
- Primary Completion
- 2026-10-01
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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