Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice

Study Overview
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Brief Summary
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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.

Detailed Description
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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: No remains Pharyngeal clearance is obtained after swallowing of test jelly once Pharyngeal clearance is obtained after swallowing of test jelly twice Pharyngeal clearance is obtained after swallowing of test jelly three times and more In spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx. 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)

Official Title
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Comparison of Pureed Rice Using a Gelling Agent and Standard Pureed Rice in Swallowing in Elderly Patients With Dysphagia

Conditions
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Swallowing Disorder

Intervention / Treatment
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* Other: a gelling agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hospitalized patients who underwent endoscopic swallowing evaluation at Showa Inan General Hospital Exclusion Criteria: an age less than 65 years old or the presence of an acute infection.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pureed rice with a gelling agent<br>3 ml of pureed rice containing a gelling agent is attempted to swallow under endoscopic examination of swallowing | Other: a gelling agent<br>* 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.<br>|
| Placebo Comparator: standard pureed rice<br>3 ml of standard pureed rice is attempted to swallow under endoscopic examination of swallowing | Other: a gelling agent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharyngeal clearance score (1-5) | No remains Pharyngeal clearance is obtained after swallowing of test jelly once Pharyngeal clearance is obtained after swallowing of test jelly twice Pharyngeal clearance is obtained after swallowing of test jelly three times and more In spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pureed diet, dysphasia