CPAP to Improve Swallow Function Post Total Laryngectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oropharyngeal Dysphagia, Laryngectomy; Status

Intervention / Treatment
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* Device: Continuous Positive Airway Pressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continue Positive Airway Pressure<br>Continue Positive Airway Pressure during VFSE | Device: Continuous Positive Airway Pressure<br>* Apex XT Fit CPAP Machine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal and hypopharyngeal transit times |  | During VFSE (1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharyngeal Constriction Ratio (PCR) |  | During VFSE (1 day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Oropharyngeal dysphagia, Total Laryngectomy, Video Fluoroscopic Swallowing Exam (VFSE)