DASH: Dysphagia Assessment in Acute Ischemic Stroke Using High-resolution Manometry

Sponsor
The Catholic University of Korea (Other)
Overall Status
Completed
CT.gov ID
NCT01683591
Collaborator
(none)
293
1
7
41.7

Study Details

Study Description

Brief Summary

Dysphagia occurs relatively commonly in patients with acute stroke, and can lead to aspiration pneumonia and malnutrition. By using the stroke registry of our hospital, we will evaluate the feasibility and usefulness of Dysphagia screening in Acute Stroke using High-resolution impedance manometry (DASH). The hypothesis tested in this study is that high-resolution impedance manometry (HRiM) can provide the clinical efficacy to evaluate dysphagia and the diet plan in acute stroke patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: High-resolution impedance manometry test

Detailed Description

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 Design

Study Type:
Observational
Actual Enrollment :
293 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Dysphagia Screening in Acute Stroke Using High-resolution Impedance Manometry (DASH); Its Implication to Diet Decision and Clinical Outcome
Study Start Date :
Apr 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • ManoScan360 and ManoScanZ (Sierra Scientific Instruments, Los Angeles, CA).
  • Outcome Measures

    Primary Outcome Measures

    1. Improvement of diet program [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).

    2. Occurrence of aspiration pneumonia [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.).

    Secondary Outcome Measures

    1. Overall satisfaction measurement regarding program [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: New stroke lesion should be present in MRI which compatible with clinical history and neurologic examination and patients with onset <= 48 hours.

    Exclusion Criteria:
    1. hyperacute stroke receiving thrombolytic therapy

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul St. Mary's Hospital Seoul Korea, Republic of 137-701

    Sponsors and Collaborators

    • The Catholic University of Korea

    Investigators

    • Principal Investigator: Joongseok Kim, MD, PhD, The Catholic University of Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joongseok Kim, Associate Professor, The Catholic University of Korea
    ClinicalTrials.gov Identifier:
    NCT01683591
    Other Study ID Numbers:
    • 060613
    First Posted:
    Sep 12, 2012
    Last Update Posted:
    Sep 12, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by Joongseok Kim, Associate Professor, The Catholic University of Korea
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 12, 2012