Brief Summary

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

Trial Health

At Risk

Trial Health Score

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

Timeline

8mo left

Started May 2022

Longer than P75 for all trials

Status

withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

4.7 years study duration

Study Progress86%

May 2022Dec 2026

First Submitted

Initial submission to the registry

July 29, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed

1.7 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected

Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

3.3 years

First QC Date

July 29, 2020

Last Update Submit

May 19, 2022

Conditions

Cardiovascular Diseases

Keywords

DysphagiaExtubationVocal Fold Mobility ImpairmentPeak Cough Flow (PCF)

Outcome Measures

Primary Outcomes (2)

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. (FEES)
Baseline (Prior to surgery)
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. (Used in both FEES and VFSS)
Follow-up - Within 72 hours following extubation from surgery and onward

Study Arms (2)

Cardiovascular Surgical Patients Preoperative Exam

All enrolled participants will undergo a baseline Fiberoptic Endoscopic Evaluation of Swallowing (FEES) before their surgery to determine baseline / preoperative swallowing function. Those with confirmed dysphagia will not be asked to complete the postoperative swallowing exam, given our desire to examine contributing risk factors for dysphagia development and mechanisms within cardiovascular surgical patients. In addition to the instrumental exam, systematic collection of demographic, medical, surgical, and intubation-related candidate predictor variables will be conducted over the entire perioperative period.

Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing

Cardiovascular Surgical Patients Postoperative Exam

All remaining participants without preoperative dysphagia will be seen for a postoperative exam performed within 48 hours of extubation. Simultaneous imaging using FEES and videofluoroscopy will be performed at the bedside, as well as a battery of clinical tests. Completion of these postoperative tests will indicate study completion for participants without evidence of dysphagia, while participants who demonstrate acute-phase postoperative dysphagia will continue to participate if they desire. During their standard of care one-month follow-up appointment, a third research evaluation will be offered for participants with previously identified postoperative dysphagia. During this exam, the same imaging and clinical tests from the previous research exam will be performed. Finally, participants with persisting dysphagia will be offered the opportunity to continue to be studied for a fourth and final research exam during their standard of care six-month follow up clinic visit.

Diagnostic Test: Fiberoptic Endoscopic Evaluation of SwallowingDiagnostic Test: Simultaneous FEES and Videofluoroscopy instrumental swallowing examOther: Voluntary Cough Peak Expiratory Flow (PEF) TestingOther: Reflex Cough ScreenOther: Lingual Pressure TestingDiagnostic Test: Speech Testing

Interventions

Fiberoptic Endoscopic Evaluation of SwallowingDIAGNOSTIC_TEST

Also known as: FEES

Cardiovascular Surgical Patients Postoperative ExamCardiovascular Surgical Patients Preoperative Exam

Simultaneous FEES and Videofluoroscopy instrumental swallowing examDIAGNOSTIC_TEST

This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism. The participant will be asked to perform some voicing tasks, once completed, a videofluoroscopic swallowing exam will occur at the same time. This is like moving x-ray of the participant swallowing foods and liquids (barium).

Also known as: Endofluoroscopy