Dysphagia Assessment in Acute Ischemic Stroke Using High-resolution Manometry

Completed

• Conditions: Ischemic Stroke
• Interventions: Procedure: High-resolution impedance manometry test

• Registration Number: NCT01683591
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Study Start: 2009-04
• Study Completion: 2009-11
• Status Verified: 2012-09
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-07
• Last Update Submitted: 2012-09-07
• Study First Posted: 2012-09-12
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intermediate-risk aspiration group	High-resolution impedance manometry test	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.

Primary Outcome Measures

Name	Time	Method
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).
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of