NCT03768739

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 3, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

December 5, 2018

Last Update Submit

November 3, 2020

Conditions

Cardiac Disease

Keywords

DysphagiaExtubationCardiac Intensive Care Unit (CICU)Forced Expiratory Volume in One second (FEV1)Peak Expiratory Flow (PEF)

Outcome Measures

Primary Outcomes (3)

  • Penetration Aspiration Scale

    This scale is a validated measure used by trained blinded clinicians to assign ratings of safety to swallowing bolus trials. The development and use of an 8-point, equal-appearing interval scale (8 being best; 1 being worst) to describe penetration and aspiration events are described. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled.

    Baseline

  • Yale Residue Severity Rating Scale

    This scale is a validated measure used by trained blinded clinicians to assign ratings of efficiency to swallowing bolus trials. The Yale Pharyngeal Residue Severity Rating Scale was developed, standardized, and validated to provide reliable, anatomically defined, and image-based assessment of post-swallow pharyngeal residue severity as observed during fiberoptic endoscopic evaluation of swallowing (FEES). It is a five-point ordinal rating scale based on residue location (vallecula and pyriform sinus) and amount (none, trace, mild, moderate, and severe)

    Baseline; Day 30

  • Vocal Fold Mobility Impairment

    Index of left and right vocal fold movement

    Baseline

Study Arms (1)

CICU extubated patients

Participants will undergo a Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

Procedure: Fiberoptic Endoscopic Evaluation of Swallowing

Interventions

Fiberoptic Endoscopic Evaluation of SwallowingPROCEDURE

This procedure involves a flexible laryngoscope that contains a light source and video camera on the end through the open passages of your nose and to the back of the throat in order to visualize the swallowing mechanism.

Also known as: FEES
CICU extubated patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

230 individuals undergoing cardiothoracic surgery will be enrolled in this study.

You may qualify if:

  • adults aged 18 - 90 years old
  • undergoing planned or emergent cardiothoracic surgery via sternotomy and/or extended thoracotomy requiring cardiopulmonary bypass
  • willing to participate in post-operative swallowing evaluation testing

You may not qualify if:

  • Patients undergoing exclusively transcatheter valves
  • Patients undergoing exclusively thoracic endovascular aortic repair procedures
  • The inability to achieve appropriate alertness and cognitive status following procedure will exclude one from completing the study.
  • Participants must pass cognition, respiratory and physical abilities screening to ensure testing safety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cardiovascular Clinic at UF Health UF

Gainesville, Florida, 32610, United States

Location

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

Thoracic and Cardiovasscular Surgery at UF Health

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • Plowman EK, Anderson A, York JD, DiBiase L, Vasilopoulos T, Arnaoutakis G, Beaver T, Martin T, Jeng EI. Dysphagia after cardiac surgery: Prevalence, risk factors, and associated outcomes. J Thorac Cardiovasc Surg. 2023 Feb;165(2):737-746.e3. doi: 10.1016/j.jtcvs.2021.02.087. Epub 2021 Mar 3.

    PMID: 33814177DERIVED

MeSH Terms

Conditions

Heart DiseasesDeglutition Disorders

Interventions

Fees and Charges

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and Organizations

Study Officials

  • Emily Plowman, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 7, 2018

Study Start

February 3, 2019

Primary Completion

September 2, 2020

Study Completion

September 2, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)