Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition - Tabular View

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

December 26, 2007

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition

Official Title ^ICMJE

Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition

Brief Summary

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

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Cross-Sectional

Condition ^ICMJE

Dysphagia

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2008

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00584623

Responsible Party

Peter C. Belafsky, MD, Ph.D., University of California Davis

Study ID Numbers ^ICMJE

200715188-1

Study Sponsor ^ICMJE

University of California, Davis

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Peter C. Belafsky, MD, PhD

University of California, Davis

Information Provided By

University of California, Davis

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP