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NCT05304416 · ClinicalTrials.gov registry record
Clinical Markers of Dysphagia in Cardiac Surgical Patients
A clinical trial of Cardiovascular Diseases and Dysphagia, sponsored by University of Florida.
- Active
- Registry status
- 347
- Enrollment target
- 2
- Study locations
NCT05304416: Active study of Cardiovascular Diseases and Dysphagia, sponsored by University of Florida.
NCT05304416 is a study of Cardiovascular Diseases and Dysphagia that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 347 participants, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05304416, a study of Cardiovascular Diseases and Dysphagia, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- 347 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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)
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Fiberoptic Endoscopic Evaluation of Swallowing
- DIAGNOSTIC_TEST Simultaneous FEES and Videofluoroscopy instrumental swallowing exam
- DIAGNOSTIC_TEST Videofluoroscopy instrumental swallowing exam (VFSS)
- OTHER Voluntary Cough Peak Expiratory Flow (PEF) Testing
- OTHER Reflex Cough Screen
Study Locations (2)
Florida
- University of Florida - Gainesville
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2022-06-07 |
| Est. Completion | 2026-12-31 |
What the registry record for NCT05304416 still lists
NCT05304416 is an observational study that tracks outcomes without assigning an intervention. The registered 347 participants enrollment target is mid-sized for trials with a published cap, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 5 interventions - of which Fiberoptic Endoscopic Evaluation of Swallowing is the first listed.
NCT05304416 reports a single indexed study location in Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT05304416 about?
NCT05304416 is a clinical study titled "Clinical Markers of Dysphagia in Cardiac Surgical Patients". 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 id...
What is the current status of trial NCT05304416?
This trial is currently active not recruiting. The enrollment target is 347 participants. The study started on 2022-06-07. Estimated completion is 2026-12-31.
What conditions does trial NCT05304416 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Dysphagia.
What interventions are being tested in trial NCT05304416?
The interventions under investigation include: Fiberoptic Endoscopic Evaluation of Swallowing (DIAGNOSTIC_TEST), Simultaneous FEES and Videofluoroscopy instrumental swallowing exam (DIAGNOSTIC_TEST), Videofluoroscopy instrumental swallowing exam (VFSS) (DIAGNOSTIC_TEST), Voluntary Cough Peak Expiratory Flow (PEF) Testing (OTHER), Reflex Cough Screen (OTHER).
Who is sponsoring clinical trial NCT05304416?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05304416 being conducted?
This trial has 2 study locations across Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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347 114th of 300 higher than 187 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
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