Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients

NCT05173207 | Completed

• 1 other identifier: IRB202102635
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic Diseases; Cardiovascular Diseases

Keywords

Dysphagia; Extubation; Respiratory-swallow coordination; Swallow

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cardiothoracic surgical patients

Subjects will undergo one simultaneous instrumental examination of swallowing and concurrent monitoring of metrics of respiratory-swallow physiology. Research exam will be performed at bedside within Cardiac \& Thoracic Intensive Care Units during their early postoperative recovery.

Diagnostic Test: Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordination

Interventions

Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordination DIAGNOSTIC_TEST

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

Cardiothoracic surgical patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 individuals undergoing cardiothoracic surgery will be enrolled in this study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Thoracic Diseases; Cardiovascular Diseases; Deglutition Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Emily K Plowman, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 29, 2021
• Study Start: March 3, 2022
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)