Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dysphagia and Vocal Cord Injury Following Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04464317
Recruitment Status : Not yet recruiting
First Posted : July 9, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease
Dysphagia Cardiovascular Diseases

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Vocal Cord Impairment and Dysphagia in Cardiac Surgery
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Incidence of vocal fold mobility impairment (VFMI) and dysphagia in postoperative cardiovascular patients [ Time Frame: January 2010-June 2020 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464317


Contacts
Layout table for location contacts
Contact: Amber R Anderson 352-273-8632 amber.anderson@ufl.edu

Locations
Layout table for location information
United States, Florida
University of Florida Health
Gainesville, Florida, United States, 32608
Contact: Amber Rae Anderson, M.S.    352-273-8632    amber.anderson@ufl.edu   
Principal Investigator: Emily K Plowman, Ph.D.         
Principal Investigator: Eric Jeng, MD         
Sponsors and Collaborators
University of Florida
Investigators
Layout table for investigator information
Principal Investigator: Emily K. Plowman, Ph.D. University of Florida
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04464317    
Other Study ID Numbers: IRB202001240
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: none at this time

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Deglutition Disorders
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases