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Clinical Trials/NCT03328702
NCT03328702
Completed
Not Applicable

Utilization of Continuous Positive Airway Pressure to Improve Swallow Function in Patients Post Total Laryngectomy

University of California, Davis1 site in 1 country4 target enrollmentJune 27, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oropharyngeal Dysphagia
Sponsor
University of California, Davis
Enrollment
4
Locations
1
Primary Endpoint
Total Pharyngeal Transit Time (With CPAP)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 27, 2016
End Date
November 8, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Total Pharyngeal Transit Time (With CPAP)

Time Frame: During VFSE (1 day)

This is the time in seconds that it takes for a bolus to move from the oral cavity, through the pharynx, and into the so. It is measured in seconds and is the primary outcome measure.

Study Sites (1)

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