Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients

July 27, 2022 updated by: University of Florida

A Preliminary Investigation of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Participants will undergo simultaneous videofluoroscopy, nasal airflow and respiratory inductance plethysmography testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Emily K Plowman, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2022

Primary Completion (Actual)

July 27, 2022

Study Completion (Actual)

July 27, 2022

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202102635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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