Clinical Markers of Dysphagia in Cardiac Surgical Patients

Active, not recruiting

• Conditions: Cardiovascular Diseases; Dysphagia
• 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; Other: Lingual Pressure Testing; Diagnostic Test: Speech Testing

• Registration Number: NCT05304416
• Lead Sponsor: University of Florida

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.

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 Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-06-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 347

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiovascular Surgical Patients Preoperative Exam	Fiberoptic Endoscopic Evaluation of Swallowing	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 Preoperative Exam	Videofluoroscopy instrumental swallowing exam (VFSS)	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	Fiberoptic Endoscopic Evaluation of Swallowing	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.
Cardiovascular Surgical Patients Preoperative Exam	Simultaneous FEES and Videofluoroscopy instrumental swallowing 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	Reflex Cough Screen	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.
Cardiovascular Surgical Patients Postoperative Exam	Lingual Pressure Testing	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.
Cardiovascular Surgical Patients Postoperative Exam	Simultaneous FEES and Videofluoroscopy instrumental swallowing 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.
Cardiovascular Surgical Patients Postoperative Exam	Videofluoroscopy instrumental swallowing exam (VFSS)	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.
Cardiovascular Surgical Patients Postoperative Exam	Voluntary Cough Peak Expiratory Flow (PEF) Testing	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.
Cardiovascular Surgical Patients Postoperative Exam	Speech Testing	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.

Primary Outcome Measures

Name	Time	Method
Penetration Aspiration Scale	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)

Secondary Outcome Measures

Name	Time	Method
Penetration Aspiration Scale	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)

Trial Locations

Locations (2)

University of Florida; 🇺🇸 Gainesville, Florida, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States