DysphagiaNCT00584545
Simultaneous Fluoroscopic and Manometric Measures of the Oropharyngeal Phase of Deglutition
An observational study of Dysphagia, run by University of California, Davis at 1 site in United States.
Trial summary
To validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dysphagia
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UCDMC otolaryngology primary clinic
Who may be able to join
- undergone pharyngeal manometry with simultaneous videofluoroscopy during the period 1/1/06 to 4/30/07
Who cannot join
- those who do not meet the inclusion criteria; pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
To validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry.
Read the 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.
- Conditions
- Dysphagia
- Keywords
- pharyngeal manometry, videofluoroscopy
- Medical subject headings
- Deglutition Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Study never got started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Belafsky, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584545
- Sponsor's protocol ID
- 200715362
- Status last verified
- Apr 2023
- First submitted
- 26 Dec 2007
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Fluoroscopic and Manometric Measures of the Oropharyngeal Phase of Deglutition
- ClinicalTrials.gov ID
- NCT00584545
- Acronym / sponsor ID
- 200715362
- Conditions
- Dysphagia
- Keywords
- pharyngeal manometry, videofluoroscopy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never got started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To validate the pharyngeal constriction ration, a surrogate measure of pharyngeal strength on fluoroscopy by comparing it with simultaneous pharyngeal manometry.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UCDMC otolaryngology primary clinic
Key inclusion criteria (1 listed)
- undergone pharyngeal manometry with simultaneous videofluoroscopy during the period 1/1/06 to 4/30/07
Key exclusion criteria (1 listed)
- those who do not meet the inclusion criteria; pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Belafsky, MD, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.