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The texture of the pureed diet is likely to be most useful factor predictive of the prevention of aspiration pneumonia. However, it has not been previously reported what kinds of texture of the pureed diet can prevent aspiration pneumonia. Using endoscopic swallowing evaluation, we attempt to compare two kinds of the pureed diets to choose the better texture of pureed diets in elderly patients with severe dysphagia.
The degree of dysphagia is evaluated using Hyodo.Komagane score (0-12). Subsequently, a randomized, crossover trial using pureed rice containing a gelling agent (Softia U, Nutri Co., Ltd., Yokkaichi, Japan), or standard pureed rice is performed in patients with dysphagia.
The extent of pharyngeal clearance after swallowing of each pureed rice and test jelly (Isotonic green jelly®, Nutri Co., Ltd., Yokkaichi, Japan) is scored as follows:
Evaluation Primary outcome: The pharyngeal clearance score (1-5) Secondary outcome: Patient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pureed rice with a gelling agent | Active Comparator | 3 ml of pureed rice containing a gelling agent is attempted to swallow under endoscopic examination of swallowing |
|
| standard pureed rice | Placebo Comparator | 3 ml of standard pureed rice is attempted to swallow under endoscopic examination of swallowing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a gelling agent | Other | Pureed rice containing a gelling agent (Softia U, Nutri Co., Ltd., Yokkaichi, Japan) is compared with the standard purred rice in the condition of swallowing. |
| Measure | Description | Time Frame |
|---|---|---|
| The pharyngeal clearance score (1-5) |
| 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient feeling regarding pharyngeal clearance | Patient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance) | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akira Horiuchi, MD | Showa Inan General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Showa Inan General hospital | Komagane | Nagano | 399-4117 | Japan |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| D010038 | Otorhinolaryngologic Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |