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Dysphagia and VFMI in Cardiac Patients

NCT ID: NCT03768739

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-03

Study Completion Date

2020-09-02

Brief Summary

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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.

Detailed Description

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Swallowing impairment and VFMI are common, yet often overlooked, complications of cardiac surgical procedures. The true incidence of both dysphagia and VFMI in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patents undergoing cardiac surgery. We therefore aimed to determine the incidence of dysphagia and VFMI in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. We also aimed to assess the relative impact of VFMI and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status.

Conditions

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Cardiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CICU extubated patients

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

Fiberoptic Endoscopic Evaluation of Swallowing

Intervention Type PROCEDURE

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.

Interventions

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Fiberoptic Endoscopic Evaluation of Swallowing

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.

Intervention Type PROCEDURE

Other Intervention Names

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FEES

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily Plowman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Cardiovascular Clinic at UF Health UF

Gainesville, Florida, United States

Site Status

UF Health at the University of Florida

Gainesville, Florida, United States

Site Status

Thoracic and Cardiovasscular Surgery at UF Health

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33814177 (View on PubMed)

Other Identifiers

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IRB201802740

Identifier Type: -

Identifier Source: org_study_id