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CPAP to Improve Swallow Function Post Total Laryngectomy

NCT ID: NCT03328702

Last Updated: 2024-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-27

Study Completion Date

2022-11-08

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.

Conditions

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Oropharyngeal Dysphagia Laryngectomy; Status

Keywords

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Dysphagia Oropharyngeal dysphagia Total Laryngectomy Video Fluoroscopic Swallowing Exam (VFSE)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Continue Positive Airway Pressure

Continue Positive Airway Pressure during VFSE

Group Type EXPERIMENTAL

Continuous Positive Airway Pressure

Intervention Type DEVICE

Apex XT Fit CPAP Machine

Interventions

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Continuous Positive Airway Pressure

Apex XT Fit CPAP Machine

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UC Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://studypages.com/s/a-study-of-continuous-positive-airway-pressure-cpap-to-improve-swallow-function-after-total-laryngectomy-784332/

Learn more or sign up for the study here!

Other Identifiers

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908521

Identifier Type: -

Identifier Source: org_study_id