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NCT03328702 Clinical Trial

CPAP to Improve Swallow Function Post Total Laryngectomy

Oropharyngeal Dysphagia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03328702
Other study ID # 908521
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2016
Est. completion date November 8, 2022

Study information
Verified date May 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date November 8, 2022
Est. primary completion date November 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Continuous Positive Airway Pressure
Apex XT Fit CPAP Machine

Locations
Country Name City State
United States UC Davis Medical Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oropharyngeal and hypopharyngeal transit times During VFSE (1 day)
Secondary Pharyngeal Constriction Ratio (PCR) During VFSE (1 day)
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