Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05173207
• Other study ID #: IRB202102635
• Status: Completed
• Start date: March 3, 2022
• Est. completion date: July 27, 2022

Study information

• Verified date: July 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Thoracic Diseases

Intervention

Diagnostic Test:
• Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordination
Participants will undergo simultaneous videofluoroscopy, nasal airflow and respiratory inductance plethysmography testing.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 year