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CPAP to Improve Swallow Function Post Total Laryngectomy

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ClinicalTrials.gov Identifier: NCT03328702
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Oropharyngeal Dysphagia Laryngectomy; Status Device: Continuous Positive Airway Pressure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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 : June 27, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Oropharyngeal and hypopharyngeal transit times [ Time Frame: During VFSE (1 day) ]

Secondary Outcome Measures :
  1. Pharyngeal Constriction Ratio (PCR) [ Time Frame: During VFSE (1 day) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328702


Contacts
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Contact: Ahmed Bayoumi, MB BCh 916-734-2863 hs-oto-study@ou.ad3.ucdavis.edu

Locations
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United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Ahmed Bayoumi, MB BCh    916-734-2863    hs-oto-study@ou.ad3.ucdavis.edu   
Sponsors and Collaborators
University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03328702     History of Changes
Other Study ID Numbers: 908521
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases