Clinical trial NCT05304416: Clinical Markers of Dysphagia in Cardiac Surgical Patients
Official title: Mechanisms, Predictors & Clinical Markers of Dysphagia in Cardiac Surgical Patients_R01
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Diseases
Dysphagia
Keywords: Cardiac surgery
Dysphagia
Extubation
Vocal Fold Mobility Impairment
Peak Cough Flow (PCF)
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Ohio State University
First posted: 2022-03-31
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Penetration Aspiration Scale
timeFrame: Baseline (Prior to surgery)
Secondary outcomes:
measure: Penetration Aspiration Scale
timeFrame: Follow-up - Within 72 hours following extubation from surgery and onward
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: University of Florida
name: Eric I Jeng, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: