Dysphagia Assessment in Acute Ischemic Stroke Using High-resolution Manometry

Ischemic Stroke Clinical Trial

— DASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683591
• Other study ID #: 060613
• Status: Completed
• Phase: N/A
• First received: September 4, 2012
• Last updated: September 7, 2012
• Start date: April 2009
• Est. completion date: November 2009

Study information

• Verified date: September 2012
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of diet program	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).	Cases were followed for the duration of hospital stay, an average of 2 weeks.	No
Primary	Occurrence of aspiration pneumonia	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.).	Cases were followed for the duration of hospital stay, an average of 2 weeks.	No
Secondary	Overall satisfaction measurement regarding program	The patients also answered as visual analogue scales that measured their level of overall satisfaction regarding improvement of their symptoms with the protocol.	1 month after study enrollment	No