Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03163355
Other study ID # 2017VE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date September 4, 2018

Study information

Verified date September 2018
Source Showa Inan General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 4, 2018
Est. primary completion date August 21, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
a gelling agent
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.

Locations

Country Name City State
Japan Showa Inan General hospital Komagane Nagano

Sponsors (1)

Lead Sponsor Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
  Status Clinical Trial Phase
Completed NCT03284892 - Screening and Intervention of Postextubation Dysphagia N/A
Completed NCT03598491 - Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation
Recruiting NCT04584658 - Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
Not yet recruiting NCT05958173 - Effects of 6-month of Treatment With TRPV1 and TRPA1 Agonists in Older Patients With OD N/A
Not yet recruiting NCT05945654 - Functional Outcome After Anastomotic Leak After Oesophagectomies
Completed NCT05098808 - Artificial Intelligence in Diagnosing Dysphagia Patients
Not yet recruiting NCT03562104 - Swallowing Disorders in Minimally Consciousness Patients (MCS) N/A
Completed NCT05678686 - Investigation of The Effects of Different Exercise Methods on Swallowing Function in Stroke Patients N/A
Recruiting NCT06250426 - Effect of a Cooling Sensation Flavor on the Swallow Response in Post-stroke Patients With Oropharyngeal Dysphagia N/A
Completed NCT04369092 - Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia N/A
Recruiting NCT05905016 - Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
Completed NCT04591665 - Correlation Between the HRIM and VFSS
Recruiting NCT05720871 - Treatment of Chronic Post-stroke Oropharyngeal Dysphagia With Paired Stimulation N/A
Completed NCT05687708 - Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia N/A
Completed NCT05832658 - Efficacy of Game-Based EMG-Biofeedback Therapy in Post-Stroke Dysphagia N/A
Completed NCT04040803 - tACS and tRNS Studies on Brain Control of Swallowing N/A
Not yet recruiting NCT06411236 - Functional Response Characteristics of Brain Under Swallowing Task Paradigm
Recruiting NCT05938166 - The Effects of Using Augmented Reality (AR) Simulation System to Train Foreign Care Workers. N/A
Completed NCT04362228 - The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia N/A
Completed NCT03907566 - The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals