Dysphagia Assessment in Acute Ischemic Stroke Using High-resolution Manometry (DASH)
|ClinicalTrials.gov Identifier: NCT01683591|
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : September 12, 2012
|Condition or disease||Intervention/treatment|
|Ischemic Stroke||Procedure: High-resolution impedance manometry test|
The hypothesis tested in this study was that high-resolution manometry can provide the clinical efficacy to evaluate dysphagia and the diet plan in acute stroke patients. By using of stroke registry of our hospital, we assessed feasibility and usefulness of Dysphagia screening in Acute Stroke using High-resolution impedance manometry in patients with acute stroke.
The registry had the contents of two evaluation steps; the first step was the process to identify the patients with risk of possible aspiration and the second step was for detection of silent aspirators.
Firstly, the patient was interviewed regarding difficulties with food intake, chewing and swallowing, and the neurological signs were confirmed by two independent neurologists. After then, the patients were stratified into three aspiration risk group and controlled by proper diet program. Finally the emergence of aspiration pneumonia was observed.
|Study Type :||Observational|
|Actual Enrollment :||293 participants|
|Official Title:||Dysphagia Screening in Acute Stroke Using High-resolution Impedance Manometry (DASH); Its Implication to Diet Decision and Clinical Outcome|
|Study Start Date :||April 2009|
|Actual Study Completion Date :||November 2009|
High-risk aspiration group
Among the consecutive stroke patients, categorized to high-risk group in the patient (1) was not on alert mentality (from drowsy to comatose mentality), (2) was not able to sit upright or control his/her head, and (3) failed to pass indirect water swallow test.
Low-risk aspiration group
Patents without oropharyngeal neurologic signs
Intermediate-risk aspiration group
If any one of following was positive, categorized to intermediate-risk group; (1) dysarthria, (2) motor aphasia, (3) inability to close and open lips or (4) facial weakness, (5) tongue deviation or (6) uvula deviation, (7) loss of gag reflex, and (8) inability to cough voluntarily.
Procedure: High-resolution impedance manometry test
The test was performed as general guideline for high-resolution impedance manometry test. The parameter was obtained and analyzed using the Chicago classification for the liquid swallows with Takasaki's modification for pharyngeal function monitoring. Swallowing pattern and aspiration risk were defined using real-time assessment of high-resolution impedance manometry test.
Other Name: ManoScan360 and ManoScanZ (Sierra Scientific Instruments, Los Angeles, CA).
- Improvement of diet program [ Time Frame: Cases were followed for the duration of hospital stay, an average of 2 weeks. ]All patients with dysphagia received swallowing rehabilitation training and were guided as per National Dysphagia Diet level or nasogastric tube feeding. These patients were monitored in terms of the improvement of dietary program (e.g., From nasogastric tube feeding to step 4 dysphagia diet).
- Occurrence of aspiration pneumonia [ Time Frame: Cases were followed for the duration of hospital stay, an average of 2 weeks. ]All patients were monitored in terms of development of aspiration pneumonia. Aspiration pneumonia was defined as typical clinical signs (fever, sputum etc.) and chest radiographic findings (X-ray and computed tomography etc.).
- Overall satisfaction measurement regarding program [ Time Frame: 1 month after study enrollment ]The patients also answered as visual analogue scales that measured their level of overall satisfaction regarding improvement of their symptoms with the protocol.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683591
|Korea, Republic of|
|Seoul St. Mary's Hospital|
|Seoul, Korea, Republic of, 137-701|
|Principal Investigator:||Joongseok Kim, MD, PhD||The Catholic University of Korea|