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

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 293

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137-701
    • Seoul St. Mary'S Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion: December 7, 2022
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 7, 2012
• First Posted (Estimate): September 12, 2012

Study Record Updates

• Last Update Posted (Estimate): September 12, 2012
• Last Update Submitted That Met QC Criteria: September 7, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Dysphagia; Acute stroke; High-resolution manometry
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Stroke; Ischemic Stroke; Ischemia; Deglutition Disorders
• Other Study ID Numbers: 060613

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No