CPAP to Improve Swallow Function Post Total Laryngectomy

Not Applicable

Completed

• Conditions: Laryngectomy; Status; Oropharyngeal Dysphagia
• Interventions: Device: Continuous Positive Airway Pressure

• Registration Number: NCT03328702
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06-27
• Study First Submitted: 2017-10-29
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-01
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-08
• Results First Submitted: 2024-07-05
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Results First Posted: 2024-12-24
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Patients at least 2 months after total laryngectomy
• Undergoing Video Fluoroscopic Swallowing Examination

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continue Positive Airway Pressure	Continuous Positive Airway Pressure	Continue Positive Airway Pressure during VFSE

Primary Outcome Measures

Name	Time	Method
Total Pharyngeal Transit Time (With CPAP)	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.

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States