Thoracic DiseasesNCT05173207
Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients
An observational study of Thoracic Diseases and Cardiovascular Diseases, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thoracic Diseases, Cardiovascular Diseases
- What is being tested?
- Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordination
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 27 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 individuals undergoing cardiothoracic surgery will be enrolled in this study.
Who may be able to join
- 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
Who cannot join
- Individuals 18 years of age or younger
- Allergies to barium
- Pregnant
- Not willing to participate in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thoracic Diseases, Cardiovascular Diseases
- Being tested
- Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordination
- Keywords
- Dysphagia, Extubation, Respiratory-swallow coordination, Swallow
- Medical subject headings
- Thoracic Diseases, Cardiovascular Diseases, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordinationDiagnostic test
Participants will undergo simultaneous videofluoroscopy, nasal airflow and respiratory inductance plethysmography testing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start3 Mar 2022
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily K Plowman, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173207
- Sponsor's protocol ID
- IRB202102635
- Status last verified
- Jul 2022
- First submitted
- 12 Nov 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Investigation of Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients
- ClinicalTrials.gov ID
- NCT05173207
- Acronym / sponsor ID
- IRB202102635
- Conditions
- Thoracic Diseases, Cardiovascular Diseases
- Keywords
- Dysphagia, Extubation, Respiratory-swallow coordination, Swallow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiothoracic surgical patients | – | Diagnostic Test: Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordinationSubjects 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 individuals undergoing cardiothoracic surgery will be enrolled in this study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Individuals 18 years of age or younger
- Allergies to barium
- Pregnant
- Not willing to participate in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordinationParticipants will undergo simultaneous videofluoroscopy, nasal airflow and respiratory inductance plethysmography testing. | Diagnostic test | Cardiothoracic surgical patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily K Plowman, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Diseases and Cardiovascular Diseases, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Aspiration Scale (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.