Dysphagia and Vocal Cord Injury Following Cardiac Surgery

NCT04464317 | Withdrawn

• 1 other identifier: IRB202001240
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dysphagia; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Under 18 years old or over 90 years old

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Deglutition Disorders; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Eric Jeng, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 9, 2020
• Study Start: August 5, 2020
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share