Cardiac DiseaseNCT03768739
Dysphagia and VFMI in Cardiac Patients
An observational study of Cardiac Disease, run by University of Florida at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Fiberoptic Endoscopic Evaluation of Swallowing
- Type of treatment
- Surgery or procedure
- How many people
- 207 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Feb 2019to 2 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 230 individuals undergoing cardiothoracic surgery will be enrolled in this study.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cardiovascular Clinic at UF Health UF
Gainesville, Florida, 32610
UF Health at the University of Florida
Gainesville, Florida, 32610
Thoracic and Cardiovasscular Surgery at UF Health
Gainesville, Florida, 32611
About this study
Official title: Dysphagia and Vocal Fold Mobility Impairment in Cardiac Surgical Patients
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.
Read the detailed description
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
- Cardiac Disease
- Being tested
- Fiberoptic Endoscopic Evaluation of Swallowing
- Keywords
- Dysphagia, Extubation, Cardiac Intensive Care Unit (CICU), Forced Expiratory Volume in One second (FEV1), Peak Expiratory Flow (PEF)
- Medical subject headings
- Heart Diseases, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiberoptic Endoscopic Evaluation of SwallowingProcedure or surgery
Also called FEES
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.
| Study group | Role | What they receive |
|---|---|---|
| CICU extubated patients | Participants will undergo a Fiberoptic Endoscopic Evaluation of Swallowing (FEES) Receives: Procedure: Fiberoptic Endoscopic Evaluation of Swallowing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Baseline; Day 30
Vocal Fold Mobility Impairment
Index of left and right vocal fold movement
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start3 Feb 2019
- Primary completion2 Sep 2020
- Study completion2 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Plowman, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768739
- Sponsor's protocol ID
- IRB201802740
- Status last verified
- Nov 2020
- First submitted
- 5 Dec 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33814177
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia and Vocal Fold Mobility Impairment in Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT03768739
- Acronym / sponsor ID
- IRB201802740
- Conditions
- Cardiac Disease
- Keywords
- Dysphagia, Extubation, Cardiac Intensive Care Unit (CICU), Forced Expiratory Volume in One second (FEV1), Peak Expiratory Flow (PEF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 3 Feb 2019 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CICU extubated patients | – | Procedure: Fiberoptic Endoscopic Evaluation of SwallowingParticipants will undergo a Fiberoptic Endoscopic Evaluation of Swallowing (FEES) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 230 individuals undergoing cardiothoracic surgery will be enrolled in this study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiberoptic Endoscopic Evaluation of SwallowingAlso: FEESThis 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. | Procedure or surgery | CICU extubated patients |
Primary outcome
Penetration Aspiration Scale
Time frame: Baseline
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.
Yale Residue Severity Rating Scale
Time frame: Baseline; Day 30
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)
Vocal Fold Mobility Impairment
Time frame: Baseline
Index of left and right vocal fold movement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 33814177Plowman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Plowman, PhD principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by University of Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Aspiration Scale (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03768739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.