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

The Catholic University of Korea

Status: Completed

Conditions: Ischemic Stroke

Treatments: Procedure: High-resolution impedance manometry test

Study type: Observational

Funder types: Other

Identifiers

NCT01683591

060613

Details and patient eligibility

About

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.

Full 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.

Enrollment: 293 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

293 participants in 3 patient groups

High-risk aspiration group

Description:

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

Description:

Patents without oropharyngeal neurologic signs

Intermediate-risk aspiration group

Description:

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.

Treatment:

Procedure: High-resolution impedance manometry test