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Simultaneous Fluoroscopic and Manometric Measures of the Oropharyngeal Phase of Deglutition

This study is ongoing, but not recruiting participants.

Sponsored by: University of California, Davis
Information provided by: University of California, Davis
ClinicalTrials.gov Identifier: NCT00584545
  Purpose

To validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry.


Condition
Dysphagia

MedlinePlus related topics:   Swallowing Disorders   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Retrospective
Official Title:   Simultaneous Fluoroscopic and Manometric Measures of the Oropharyngeal Phase of Deglutition

Further study details as provided by University of California, Davis:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   15
Study Start Date:   June 2007
Estimated Study Completion Date:   June 2008
Estimated Primary Completion Date:   June 2008 (Final data collection date for primary outcome measure)

Detailed Description:

The specific aim of this study is to validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry. Combined videofluoroscopic swallowing studies with pharyngeal manometry are commonly used in the evaluation of dysphagia. However, no published study has compared the results of simultaneous pharyngeal manometry with objective timing and displacement measures on videofluoroscopy. These objective measures, such as the pharyngeal constriction ratio, were developed here at UCD and are not yet routinely used by other practitioners. A secondary aim of this study will be to corroborate recent data in the literature suggesting that the presence of feeding tube through the upper esophageal sphincter does not affect the oropharyngeal phase of deglutition. This topic is currently under hot debate in the speech language pathology realm and has important implications for the evaluation of hospitalized patients with dysphagia.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

Study Population

UCDMC otolaryngology primary clinic


Criteria

Inclusion Criteria:

  • undergone pharyngeal manometry with simultaneous videofluoroscopy during the period 1/1/06 to 4/30/07

Exclusion Criteria:

  • those who do not meet the inclusion criteria; pregnancy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584545

Locations
United States, California
University of California Davis Medical Center    
      Sacramento, California, United States, 95817

Sponsors and Collaborators
University of California, Davis

Investigators
Principal Investigator:     Peter Belafsky, MD, PhD     University of California, Davis    
  More Information


Responsible Party:   University of California Davis ( Peter Belafsky, MD, Ph.D. )
Study ID Numbers:   200715362-1
First Received:   December 26, 2007
Last Updated:   December 26, 2007
ClinicalTrials.gov Identifier:   NCT00584545
Health Authority:   United States: Institutional Review Board

Keywords provided by University of California, Davis:
pharyngeal manometry  
videofluoroscopy  

Study placed in the following topic categories:
Deglutition Disorders
Otorhinolaryngologic Diseases
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Esophageal Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on October 28, 2008




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