Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Dysphagia in Stroke Patients
Recruitment status was Not yet recruiting
|First Received Date ICMJE||November 25, 2010|
|Last Updated Date||November 26, 2010|
|Start Date ICMJE||December 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01249300 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Comparison of Ultrasound and Videofluoroscopic Imaging Techniques in Diagnosing Dysphagia in Stroke Patients|
|Official Title ICMJE||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 Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
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 ICMJE||Other: No intervention
|Study Group/Cohort (s)||Dysphagia
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 ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||30|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||20 Years to 70 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Taiwan|
|NCT Number ICMJE||NCT01249300|
|Other Study ID Numbers ICMJE||DMR99-IRB-130|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Nai-Hsin Meng, China Medical University Hospital|
|Study Sponsor ICMJE||China Medical University Hospital|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||China Medical University Hospital|
|Verification Date||November 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP