Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition

This study is ongoing, but not recruiting participants.

First Received: December 26, 2007 No Changes Posted

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00584623

Purpose

To correlate findings between two commonly-used types of swallowing studies: videofluoroscopy and flexible endoscopic evaluation of swallowing (FEES).

Condition
Dysphagia

Study Type:	Observational
Study Design:	Case-Only, Cross-Sectional
Official Title:	Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Swallowing Disorders

U.S. FDA Resources

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	75
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Detailed Description:

The specific aim of this study is to correlate findings between two commonly-used types of swallowing studies:

videofluoroscopy and flexible endoscopic evaluation of swallowing (FEES). Specifically, the timing of swallowing events will be correlated between teh two studies. In addition, the pharyngeal constriction ratio (a validated measure of pharyngeal strength on videofluoroscopy) will be compared with the pharyngeal squeeze maneuver (an assessment of pharyngeal strength on FEES), with the hypothesis that there will be a strong correlation between PCR and pharyngeal squeeze.

Eligibility

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

Study Population

Adult clinic population in the UCD Otolaryngology Clinic

Criteria

Inclusion Criteria:

complaints of dysphagia
scheduled to undergo videofluoroscopy
able to tolerate both videofluoroscopic evaluation of swallowing and FEES

Exclusion Criteria:

age less than 18
contraindications to videofluoroscopy (reaction to barium, possible pregnancy)
contraindications to FEES (bilateral obstructing nasal pathology or nasopharyngeal stenosis)
specific/vulnerable populations (children, mentally handicapped, pregnant women, fetuses, prisoners, cognitive impairment, life-threatening disease, social or economic disadvantage)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584623

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 C. Belafsky, MD, PhD

University of California, Davis

More Information

No publications provided

Responsible Party:	University of California Davis ( Peter C. Belafsky, MD, Ph.D. )
Study ID Numbers:	200715188-1
Study First Received:	December 26, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00584623 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

dysphagia
videofluoroscopy
flexible endoscopic evaluation

Study placed in the following topic categories:

Deglutition Disorders
Otorhinolaryngologic Diseases
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Esophageal Diseases
Pharyngeal Diseases

Additional relevant MeSH terms:

Deglutition Disorders
Otorhinolaryngologic Diseases
Digestive System Diseases

Gastrointestinal Diseases
Esophageal Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on September 10, 2009