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Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584623
First received: December 26, 2007
Last updated: December 16, 2010
Last verified: December 2010
History of Changes
  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: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition

Resource links provided by NLM:

U.S. FDA Resources

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

Enrollment: 0
Study Start Date: March 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (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: Peter C. Belafsky, MD, Ph.D., University of California Davis
ClinicalTrials.gov Identifier: NCT00584623     History of Changes
Other Study ID Numbers: 200715188-1
Study First Received: December 26, 2007
Last Updated: December 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
dysphagia
videofluoroscopy
flexible endoscopic evaluation

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013