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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joongseok Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01683591
First received: September 4, 2012
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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 Intervention
Ischemic Stroke
Procedure: High-resolution impedance manometry test

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Improvement of diet program [ Time Frame: Cases were followed for the duration of hospital stay, an average of 2 weeks. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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:
  • Overall satisfaction measurement regarding program [ Time Frame: 1 month after study enrollment ] [ Designated as safety issue: No ]
    The patients also answered as visual analogue scales that measured their level of overall satisfaction regarding improvement of their symptoms with the protocol.


Enrollment: 293
Study Start Date: April 2009
Study Completion Date: November 2009
Groups/Cohorts Assigned Interventions
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).

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute ischemic stroke patients at neurology department from April 2009 to November 2009 were evaluated.

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01683591

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Joongseok Kim, Associate Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01683591     History of Changes
Other Study ID Numbers: 060613
Study First Received: September 4, 2012
Last Updated: September 7, 2012
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by The Catholic University of Korea:
Acute stroke
Dysphagia
High-resolution manometry

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 22, 2014