Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients

Dysphagia (swallowing impairment) is a common complication of cardiothoracic surgery (CS). Although alterations in respiratory-swallow coordination is a known underlying pathophysiologic mechanism of dysphagia in multiple patient populations, no group has examined respiratory-swallow physiology in CS patients. The proposed study will examine respiratory-swallow physiology in CS patients and determine its association with unsafe swallowing and inferior health-related outcomes.

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Key information

Conditions

Thoracic Diseases Cardiovascular Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

The proposed study will examine respiratory-swallow physiology in cardiothoracic surgical patients and determine its association with unsafe swallowing and inferior health-related outcomes. Participation will involve a single postoperative research exam of approximately 60-90 minute duration. Participants will be seated upright and positioned for simultaneous instrumental imaging of swallow physiology, nasal airflow monitoring, and respiratory inductance plethysmography testing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults over 18 years of age who have undergone cardiothoracic surgery at UF Health
No allergies to barium
Not pregnant
Willing to participate in study

Exclusion criteria

Individuals 18 years of age or younger
Allergies to barium
Pregnant
Not willing to participate in study

Treatment and study plan

Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordination

Diagnostic Test

Participants will undergo simultaneous videofluoroscopy, nasal airflow and respiratory inductance plethysmography testing.

Primary outcomes

Penetration Aspiration Scale

Time frame: Up to 1 year

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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

A Preliminary Investigation of Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Dec 29, 2021
Registry last updated: Jul 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed