Clinical trial NCT04496986: Dysphagia in Cardiac Surgical Patients_
Official title: Mechanisms, Predictors and Clinical Markers of Dysphagia in Cardiac Surgical Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiovascular Diseases
Keywords: Dysphagia
Extubation
Vocal Fold Mobility Impairment
Peak Cough Flow (PCF)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 0
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: 360 individuals undergoing cardiac surgery will be enrolled in this study.

Brief summary: The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing cardiovascular surgical procedures. It also seeks to determine the impact of postoperative swallowing impairment on health-related outcomes.

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. We will identify risk factors for postoperative dysphagia and VFMI in cardiovascular patients to build a practical electronic risk-stratification tool. We also aim to identify sensitive bedside clinical markers of dysphagia in postoperative cardiovascular patients to develop a bedside screening tool. All participants 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. Finally, health-related outcomes will be indexed in enrolled participants to determine the impact of dysphagia.

Eligibility criteria: Inclusion Criteria: 1) individuals over 18 years of age, 2) undergoing a cardiovascular procedure at the University of Florida Heart and Vascular Hospital, 3) confirmed negative COVID-19 test result, 4) no allergies to barium, 5) not pregnant (female participants), and 6) willing to participate in research exams.

Exclusion Criteria: 1) individuals under the age of 18, 2) patients with a confirmed positive COVID-19 test result, 3) participants with allergies to barium, 4) pregnant women, or 5) unwilling to participate in research exams.

Primary outcomes:
measure: Penetration Aspiration Scale
timeFrame: Baseline (Prior to surgery)
measure: Penetration Aspiration Scale
timeFrame: Follow-up - Within 72 hours following extubation from surgery and onward
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Emily K Plowman, PhD
role: PRINCIPAL_INVESTIGATOR
References: