Dysphagia Assessment in Acute Ischemic Stroke Using High-resolution Manometry
NCT ID: NCT01683591
Last Updated: 2012-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
293 participants
OBSERVATIONAL
2009-04-30
2009-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Low-risk aspiration group
Patents without oropharyngeal neurologic signs
No interventions assigned to this group
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Exclusion Criteria
2. symptom onset \> 48 hours
3. patients who died in the incipient stage of acute stroke
4. neurological deterioration (increase in NIHSS ≥ 4)
5. transient ischemic attack
6. history of prior stroke and dysphagia
7. other neurological diseases causing oropharyngeal dysphagia, such as Parkinsonism, dementia, and neuromuscular disorders
8. history of cranial neurosurgery
9. prior or current structural lesions causing oropharyngeal dysphagia,
10. pulmonary diseases such as chronic obstructive pulmonary disease or current pneumonia.
ALL
No
Sponsors
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The Catholic University of Korea
OTHER
Responsible Party
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Joongseok Kim
Associate Professor
Principal Investigators
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Joongseok Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Locations
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Seoul St. Mary's Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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060613
Identifier Type: -
Identifier Source: org_study_id