CPAP to Improve Swallow Function Post Total Laryngectomy

• Sponsor: University of California, Davis (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03328702
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 89.1
• Patients Per Site Per Month: 0.1

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Oropharyngeal Dysphagia; Laryngectomy; Status	Device: Continuous Positive Airway Pressure	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Utilization of Continuous Positive Airway Pressure to Improve Swallow Function in Patients Post Total Laryngectomy
• Actual Study Start Date: Jun 27, 2016
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Continue Positive Airway Pressure Continue Positive Airway Pressure during VFSE	Device: Continuous Positive Airway Pressure; Apex XT Fit CPAP Machine

Outcome Measures

Primary Outcome Measures

1. Oropharyngeal and hypopharyngeal transit times [During VFSE (1 day)]

Secondary Outcome Measures

1. Pharyngeal Constriction Ratio (PCR) [During VFSE (1 day)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Medical Center	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Learn more or sign up for the study here!

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03328702
• Other Study ID Numbers: 908521
• First Posted: Nov 1, 2017
• Last Update Posted: Jan 28, 2022
• Last Verified: Jan 1, 2022

• 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
• Keywords provided by University of California, Davis: Dysphagia; Oropharyngeal dysphagia; Total Laryngectomy; Video Fluoroscopic Swallowing Exam (VFSE)
• Additional relevant MeSH terms: Deglutition Disorders

Study Results

No Results Posted as of Jan 28, 2022