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NCT04464317 Clinical Trial

Dysphagia and Vocal Cord Injury Following Cardiac Surgery

Cardiovascular Diseases Clinical Trial

Official title:
Vocal Cord Impairment and Dysphagia in Cardiac Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04464317
Other study ID # IRB202001240
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 5, 2020
Est. completion date June 13, 2023

Study information
Verified date June 2023
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 13, 2023
Est. primary completion date June 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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