Back to resultsCPAP to Improve Swallow Function Post Total Laryngectomy
Primary Purpose
Oropharyngeal Dysphagia, Laryngectomy; Status
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure
Sponsored by
About this trial
This is an interventional supportive care trial for Oropharyngeal Dysphagia focused on measuring Dysphagia, Oropharyngeal dysphagia, Total Laryngectomy, Video Fluoroscopic Swallowing Exam (VFSE)
Eligibility Criteria
Inclusion Criteria:
- Patients at least 2 months after total laryngectomy
- Undergoing Video Fluoroscopic Swallowing Examination
Exclusion Criteria:
- Patients with 100% neopharyngeal stenosis
- Patients with active cancer within 2 months of the study
- Patients with pharyngocutaneous fistula
- Vulnerable population: Adults unable to consent, Pregnant women, and Prisoners
Sites / Locations
- UC Davis Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Continue Positive Airway Pressure
Arm Description
Continue Positive Airway Pressure during VFSE
Outcomes
Primary Outcome Measures
Oropharyngeal and hypopharyngeal transit times
Secondary Outcome Measures
Pharyngeal Constriction Ratio (PCR)
Full Information
NCT ID
NCT03328702
First Posted
October 29, 2017
Last Updated
May 30, 2023
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03328702
Brief Title
CPAP to Improve Swallow Function Post Total Laryngectomy
Official Title
Utilization of Continuous Positive Airway Pressure to Improve Swallow Function in Patients Post Total Laryngectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 27, 2016 (Actual)
Primary Completion Date
November 8, 2022 (Actual)
Study Completion Date
November 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigator initiated prospective study to determine whether use of Continuous Positive Airway Pressure (CPAP) can improve the swallow function in patients who underwent total laryngectomy and are experiencing difficulty swallowing
Detailed Description
Total laryngectomy is a procedure that involves surgical removal of the larynx and separation of the digestive and airway tracts. The procedure is typically conducted for cases of laryngeal cancer and intractable aspiration. Following this procedure, patients are no longer at risk for aspiration; however some patients continue to experience difficulties in propulsion of food or drink throughout the pharynx. Previous research has demonstrated a reduction in pharyngeal contractile pressure and increased pharyngeal transit time in patients post laryngectomy. Continuous Positive Airway Pressure (CPAP) may assist bolus propulsion in these patients by increasing pressure in the direction of bolus flow. This study aims to evaluate the utility of a CPAP mask to improve pharyngeal swallow outcomes during Video Fluoroscopic Swallowing Exam (VFSE) in patients with dysphagia following total laryngectomy. This specific population could be well-suited for this application, since the digestive tract and airway are completely separate and there is no risk of the aspiration into the airway.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Dysphagia, Laryngectomy; Status
Keywords
Dysphagia, Oropharyngeal dysphagia, Total Laryngectomy, Video Fluoroscopic Swallowing Exam (VFSE)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continue Positive Airway Pressure
Arm Type
Experimental
Arm Description
Continue Positive Airway Pressure during VFSE
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure
Intervention Description
Apex XT Fit CPAP Machine
Primary Outcome Measure Information:
Title
Oropharyngeal and hypopharyngeal transit times
Time Frame
During VFSE (1 day)
Secondary Outcome Measure Information:
Title
Pharyngeal Constriction Ratio (PCR)
Time Frame
During VFSE (1 day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients at least 2 months after total laryngectomy
Undergoing Video Fluoroscopic Swallowing Examination
Exclusion Criteria:
Patients with 100% neopharyngeal stenosis
Patients with active cancer within 2 months of the study
Patients with pharyngocutaneous fistula
Vulnerable population: Adults unable to consent, Pregnant women, and Prisoners
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Links:
URL
https://studypages.com/s/a-study-of-continuous-positive-airway-pressure-cpap-to-improve-swallow-function-after-total-laryngectomy-784332/
Description
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CPAP to Improve Swallow Function Post Total Laryngectomy
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