Dysphagia and Vocal Cord Injury Following Cardiac Surgery

Vocal Cord Impairment and Dysphagia in Cardiac Surgery

Aiming to determine the incidence and contributing risk factors of vocal fold mobility impairment (VFMI) and dysphagia in postoperative cardiovascular patients and evaluate the impact of VFMI on health-related outcomes.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Diseases; Dysphagia

Detailed Description

This is a retrospective study to determine:

1. the incidence and contributing risk factors of vocal fold mobility impairment (VFMI) and dysphagia in postoperative cardiovascular patients
2. evaluate the impact of VFMI on health-related outcomes.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone an elective, urgent, and/or emergent cardiovascular surgery via endovascular or open (sternotomy and/or extended thoracotomy) technique at the University of Florida Health.

Description

Inclusion Criteria:

• All cardiac surgery patients January 2010-April 2020 at Shands Hospital
• Patients aged between 18 and 90 years
• Undergone an elective, urgent, and/or emergent cardiovascular surgery via endovascular or open (sternotomy and/or extended thoracotomy) technique at the University of Florida Health.

Exclusion Criteria:

• Under 18 years old or over 90 years old

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patient who has had cardiovascular surgery; Undergone an elective, urgent, and/or emergent cardiovascular surgery via endovascular or open (sternotomy and/or extended thoracotomy) technique at the University of Florida Health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of vocal fold mobility impairment (VFMI) and dysphagia in postoperative cardiovascular patients	Data analyses will be conducted using commercially available statistical software, SPSS and only de-identified data will be used during data analysis. We will pull data from the files in order to determine how often the patients have vocal fold mobility impairment and/or dysphagia following surgery.	January 2010-June 2020

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Eric Jeng, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Estimated): June 13, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Cardiovascular Diseases; Deglutition Disorders
• Other Study ID Numbers: IRB202001240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: none at this time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No