CPAP to Improve Swallow Function Post Total Laryngectomy

May 30, 2023 updated by: University of California, Davis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oropharyngeal and hypopharyngeal transit times
Time Frame: During VFSE (1 day)
During VFSE (1 day)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharyngeal Constriction Ratio (PCR)
Time Frame: During VFSE (1 day)
During VFSE (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2016

Primary Completion (Actual)

November 8, 2022

Study Completion (Actual)

November 8, 2022

Study Registration Dates

First Submitted

October 29, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 908521

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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