Clinical trial NCT01683591: Dysphagia Assessment in Acute Ischemic Stroke Using High-resolution Manometry
Official title: Dysphagia Screening in Acute Stroke Using High-resolution Impedance Manometry (DASH); Its Implication to Diet Decision and Clinical Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: Acute stroke
Dysphagia
High-resolution manometry
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 293
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients at neurology department from April 2009 to November 2009 were evaluated.

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.

Eligibility 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.

Primary outcomes:
measure: Improvement of diet program
timeFrame: Cases were followed for the duration of hospital stay, an average of 2 weeks.
measure: Occurrence of aspiration pneumonia
timeFrame: Cases were followed for the duration of hospital stay, an average of 2 weeks.
Secondary outcomes:
measure: Overall satisfaction measurement regarding program
timeFrame: 1 month after study enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Joongseok Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: