UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048144 |
|---|---|
| Receipt number | R000054866 |
| Scientific Title | Effects of carbonated thickened drinks on pharyngeal swallowing with Flexible Endoscopic Evaluation of Swallowing in patients of oropharyngeal dysphagia |
| Date of disclosure of the study information | 2022/06/27 |
| Last modified on | 2022/12/22 11:30:47 |
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Basic information
Public title
Evaluation of the effect of carbonated thickened drinks on improving swallowing in patients with dysphagia
Acronym
Effects of carbonated thickened drinks on improving swallowing
Scientific Title
Effects of carbonated thickened drinks on pharyngeal swallowing with Flexible Endoscopic Evaluation of Swallowing in patients of oropharyngeal dysphagia
Scientific Title:Acronym
Effects of carbonated thickened drinks with Flexible Endoscopic Evaluation of Swallowing
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Oto-rhino-laryngology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our study aims to determine the effect of sweetened carbonated thickened drink on penetration and/or aspiration, pharyngeal residue, and swallowing reflex in patients with dysphagia using Flexible Endoscopic Evaluation of Swallowing (FEES) and to identify differences in swallowing behavior versus other liquids.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aspiration is assessed with the Penetration-Aspiration Scale (PAS) based on Flexible Endoscopic Evaluation of Swallowing (FEES)
Key secondary outcomes
Pharyngeal residue and swallowing reflex initiation were evaluate based on FEES.
The patient's subjective difficulty in swallowing.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients swallow four liquids: Thin liquid(water), thickened water, thin carbonated drink, and carbonated thickend drink with a 5-minute interval.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent FEES for the diagnosis of dysphagia at Yokohama Izumidai Hospital between 2021 and 2022 were included in this study.
Key exclusion criteria
Exclusion criteria were age less than 18 years and subjects with cognitive dysfunction that prevented hearing and subjective difficulty swallowing liquids.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Motoyoshi |
| Middle name | |
| Last name | Morishita |
Organization
Kibi International University
Division name
Department of Physical Therapy
Zip code
716-8508
Address
8, Iga-machi, Takahashi, Okayama
TEL
0866-22-9465
m_mori@kiui.ac.jp
Public contact
Name of contact person
| 1st name | Motoyoshi |
| Middle name | |
| Last name | Morishita |
Organization
Kibi International Univerisity
Division name
Department of Physical Therapy
Zip code
716-8508
Address
8, Iga-machi, Takahashi, Okayama
TEL
0866-22-9465
Homepage URL
m_mori@kiui.ac.jp
Sponsor or person
Institute
Yokohama Izumidai Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Kibi International University
Address
8, Iga-machi, Takahashi, Okayama
Tel
0866-22-9454
t-kuroda@office.jei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜いずみ台病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3390/healthcare10091769
Number of participants that the trial has enrolled
13
Results
Penetration aspiration scale was significantly lower in the carbonated thickened drink than the thin water (p<0.05). Swallowing reflex initiation was significantly different between the thin and thickened drink (p<0.01) ; moreover, post hoc analysis revealed that it was significantly lower in the carbonated thickened drink than the thin water (p<0.01). The subjective difficulty of swallowing in the carbonated thickened drink was significantly lower than the thickened water (p<0.05).
Results date posted
| 2022 | Year | 12 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 14 | Day |
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Penetration Aspiration Scale, Yale Pharyngeal Residue Severity Rating Scale, Hyodo score, The subjective difficulty of swallowing
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054866
