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Clinical Trials/NCT04487028
NCT04487028
Completed
Not Applicable

Dysphagia in Thoracic Surgical Patients: Incidence, Risk-factors, and Health Related Outcomes

University of Florida3 sites in 1 country61 target enrollmentAugust 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thoracic Diseases
Sponsor
University of Florida
Enrollment
61
Locations
3
Primary Endpoint
Penetration Aspiration Scale
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing throacic 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 thoracic 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 thoracic surgery. The study is 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. In addition, the study is 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

Registry
clinicaltrials.gov
Start Date
August 25, 2020
End Date
November 22, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • adults aged 18 - 90 years old
  • undergoing planned or emergent thoracic surgery via clamshell and/or extended thoracotomy
  • confirmed negative COVID-19 test
  • willing to participate in postoperative swallowing evaluation testing.

Exclusion Criteria

  • individuals under the age of
  • or those testing positive for COVID-19
  • Additionally, the inability to demonstrate appropriate alertness and cognitive status following the procedure will exclude a participant from participating in this study to ensure protection of vulnerable individuals.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Yale Residue Severity Rating Scale(Baseline)

Study Sites (3)

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