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

Not Applicable

Completed

• Conditions: Swallowing Disorder
• Interventions: Other: a gelling agent

• Registration Number: NCT03163355
• Lead Sponsor: Showa Inan General Hospital

Brief Summary

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

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)

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-20
• Study First Submitted QC: 2017-05-20
• Study First Posted: 2017-05-23
• Primary Completion: 2018-08-21
• Status Verified: 2018-09
• Study Completion: 2018-09-04
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
pureed rice with a gelling agent	a gelling agent	3 ml of pureed rice containing a gelling agent is attempted to swallow under endoscopic examination of swallowing
standard pureed rice	a gelling agent	3 ml of standard pureed rice is attempted to swallow under endoscopic examination of swallowing

Primary Outcome Measures

Name	Time	Method
The pharyngeal clearance score (1-5)	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Patient feeling regarding pharyngeal clearance	24 months	Patient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance)

Trial Locations

Locations (1)

Showa Inan General hospital; 🇯🇵 Komagane, Nagano, Japan