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

Showa Inan General Hospital

Status: Completed

Conditions: Swallowing Disorder

Treatments: Other: a gelling agent

Study type: Interventional

Funder types: Other

Identifiers

NCT03163355

2017VE

Details and patient eligibility

About

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.

Full description

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:

1. No remains
2. Pharyngeal clearance is obtained after swallowing of test jelly once
3. Pharyngeal clearance is obtained after swallowing of test jelly twice
4. Pharyngeal clearance is obtained after swallowing of test jelly three times and more
5. 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)

Enrollment: 50 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

pureed rice with a gelling agent

Active Comparator group

Description:

3 ml of pureed rice containing a gelling agent is attempted to swallow under endoscopic examination of swallowing

Treatment:

Other: a gelling agent

standard pureed rice

Placebo Comparator group

Description:

3 ml of standard pureed rice is attempted to swallow under endoscopic examination of swallowing

Treatment:

Other: a gelling agent