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Dysphagia Assessment in Acute Ischemic Stroke Using High-resolution Manometry

Dysphagia Screening in Acute Stroke Using High-resolution Impedance Manometry (DASH); Its Implication to Diet Decision and Clinical Outcome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01683591
Acronym
DASH
Enrollment
293
Registered
2012-09-12
Start date
2009-04-30
Completion date
2009-11-30
Last updated
2012-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Acute stroke, Dysphagia, High-resolution manometry

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.

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.

Interventions

PROCEDUREHigh-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.

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
Improvement of diet programCases 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 pneumoniaCases 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

MeasureTime frameDescription
Overall satisfaction measurement regarding program1 month after study enrollmentThe patients also answered as visual analogue scales that measured their level of overall satisfaction regarding improvement of their symptoms with the protocol.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026