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Dysphagia in Thoracic Surgical Patients

NCT ID: NCT04487028

Last Updated: 2021-11-24

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

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-25

Study Completion Date

2021-11-22

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 throacic 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 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

Conditions

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Thoracic Diseases

Keywords

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Dysphagia Extubation Vocal Fold Mobility Impairment Peak Cough Flow (PCF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Thoracic Surgical Patients

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

Fiberoptic Endoscopic Evaluation of Swallowing

Intervention Type PROCEDURE

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.

Interventions

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Fiberoptic Endoscopic Evaluation of Swallowing

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.

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 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 18.
* pregnant
* 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.
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 K 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

Thoracic and Cardiovasscular Surgery at UF Health

Gainesville, Florida, United States

Site Status

UF Health at the University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB202000724-A

Identifier Type: -

Identifier Source: org_study_id