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ACTIVE NOT RECRUITING
NCT05304416

Clinical Markers of Dysphagia in Cardiac Surgical Patients

Sponsor: University of Florida

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

347

Start Date

2022-06-07

Completion Date

2026-12-31

Last Updated

2025-10-14

Healthy Volunteers

No

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."

Locations (2)

University of Florida

Gainesville, Florida, United States

The Ohio State University

Columbus, Ohio, United States