Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Dysphagia in Stroke Patients
|ClinicalTrials.gov Identifier: NCT01249300|
Recruitment Status : Unknown
Verified November 2010 by China Medical University Hospital.
Recruitment status was: Not yet recruiting
First Posted : November 29, 2010
Last Update Posted : November 29, 2010
|First Submitted Date||November 25, 2010|
|First Posted Date||November 29, 2010|
|Last Update Posted Date||November 29, 2010|
|Study Start Date||December 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Dysphagia in Stroke Patients|
|Official Title||Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Dysphagia in Stroke Patients|
Introduction Patients with stroke may be silent aspirators or at risk for laryngeal penetration or aspiration because of abnormal oropharyngeal functioning and thus are at risk for aspiration pneumonia and its serious effects. By providing identification of the components of the abnormal swallow, and comparing swallowing across tasks, the investigators may avoid aspiration and can instruct patients on preventative or compensatory swallowing techniques.
Materials and methods
The investigators will study the oral, pharyngeal and upper esophageal phases of swallow using videofluoroscopy and correlate with ultrasound tracing of epiglottis movement in patients with stroke conditions. Most of the previous studies of swallowing have utilized diagnostic imaging technique to provide a complete swallowing assessment, but limited capabilities for screening large population of patients.
INCLUSION CRITERIA: The Stroke Center inpatients and outpatients with known or suspected dysphagia can be included for study as well as patients who are admitted specifically for this protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or choking when eating, shortness of breath during swallowing, food backing up into the mouth or nasal passage, fever or voice changes after swallowing, pain when swallowing, unexplained loss of weight.
EXCLUSION CRITERIA: Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions. Non-ambulatory patients will be excluded if they cannot be braced or supported within the fluoroscopy unit. Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment.
Analytic Methods The Student t test will be used to analyze the difference in epiglottis movements during swallowing amongst different phases. Levene's test for equality of variances will be applied to examine the variability of epiglottis movements during swallowing between the groups. All statistical analysis will be performed with SPSS.
|Detailed Description||Not Provided|
|Study Design||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||The Stroke Center inpatients and outpatients with known or suspected dysphagia can be included for study as well as patients who are admitted specifically for this protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or choking when eating, shortness of breath during swallowing, food backing up into the mouth or nasal passage, fever or voice changes after swallowing, pain when swallowing, unexplained loss of weight.|
|Intervention||Other: No intervention
Patients with CVA which causes dysphagia
Intervention: Other: No intervention
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status||Unknown status|
|Original Estimated Enrollment||Same as current|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Ages||20 Years to 70 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Taiwan|
|Removed Location Countries|
|Other Study ID Numbers||DMR99-IRB-130|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Nai-Hsin Meng, China Medical University Hospital|
|Study Sponsor||China Medical University Hospital|
|PRS Account||China Medical University Hospital|
|Verification Date||November 2010|