Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients

Completed

• Conditions: Thoracic Diseases; Cardiovascular Diseases
• Interventions: Diagnostic Test: Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordination

• Registration Number: NCT05173207
• Lead Sponsor: University of Florida

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-29
• Study Start: 2022-03-03
• Status Verified: 2022-07
• Primary Completion: 2022-07-27
• Study Completion: 2022-07-27
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiothoracic surgical patients	Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordination	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.

Primary Outcome Measures

Name	Time	Method
Penetration Aspiration Scale	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States