UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034515 |
|---|---|
| Receipt number | R000039275 |
| Scientific Title | Comparison between bedside evaluation and evaluation using equipment on dysphagia patient. |
| Date of disclosure of the study information | 2018/12/17 |
| Last modified on | 2020/10/21 11:18:52 |
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Basic information
Public title
Comparison between bedside evaluation and evaluation using equipment on dysphagia patient.
Acronym
Comparison between bedside evaluation and evaluation using equipment on dysphagia patient.
Scientific Title
Comparison between bedside evaluation and evaluation using equipment on dysphagia patient.
Scientific Title:Acronym
Comparison between bedside evaluation and evaluation using equipment on dysphagia patient.
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When a patient with dysphagia eats a certain food type, it compares with the result of VF or VE to ascertain how much the observation evaluation can correctly detect the symptoms.
Basic objectives2
Others
Basic objectives -Others
Comparing the food type chosen in the observation evaluation table with the food type selected by VF or VE.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Eating observation evaluation by food type, VF or VE result
Key secondary outcomes
Details when the result obtained from the observation evaluation table is different from the result of VF or VE
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*A patient in charge who is diagnosed as having eating dysphagia and who is scheduled to perform VF for food form determination
*can be ingested orally
*Person who obtained written informed consent
Key exclusion criteria
Those who have judged that the research director is inappropriate for incorporation into research
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Jnko |
| Middle name | |
| Last name | Fujitani |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
0332027181
jufujita@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Juno |
| Middle name | |
| Last name | Fujitani |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
0332027181
Homepage URL
jufujita@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center Golobal Health and Medicine
department of rehabilitation medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1 toyama shinjuku-ku Tokyo, Japan
Tel
0332027181
kenkyu-sinsa@hosp.ncgm.go.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
国立国際医療研究センター 他
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
http://hosp.ncgm.go.jp/s027/index.html
Publication of results
Published
Result
URL related to results and publications
http://hosp.ncgm.go.jp/s027/index.html
Number of participants that the trial has enrolled
155
Results
Meal observation determined that 88 subjects were unable to ingest food orally, while 444 were able. Both VF and VE demonstrated that 68 were unable while 464 were able. With GUSS, 232 were unable and 300 were able. Therefore, the meal observation assessment table exhibited sensitivity of 86.9% and specificity of 39.7% . In addition, laterally asymmetrical movements of the corners of the mouth, was useful in choosing safe foods that require mastication.
Results date posted
| 2020 | Year | 10 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among cases that were diagnosed with dysphagia with ability to orally ingest food by the joint research facilities, and had VF or VE performed to determine the appropriate food type, we selected those who provided written consent to participate in the study.
Participant flow
multi-facility traial
Adverse events
no
Outcome measures
*Mastication was estimated based on external appearance of laterally asymmetrical movements of the corners of the mouth.
*We assessed whether subjects can swallow food or not, and if there was a delay.
*We observed whether the subject choked before, during, and after swallowing, and
judged whether coughing occurred, as if the subject had something in their throat.
*Cervical auscultation was employed to determine if there was any abnormal swallowing sound or respiration sound after swallowing. We assessed abnormal sounds, such as long swallowing sound, weak swallowing sound, bubbling sound during swallowing, expectoration sound associated with coughing, muddy and wet sound immediately after swallowing, hoarseness, and the sound of liquid vibrating.
*Drooling was assessed by presence or absence of flowing saliva from the moment subject put food in their mouth, and during mastication, to swallowing.
*Voice change was assessed by having subject say eeeh after swallowing and observing for changes such as wet hoarse voice.
*Respiration was observed for changes during meals, specifically shallow and fast respiration after swallowing.
*Oral residue was assessed by observing oral cavity residue after swallowing. If there was any residue, it was categorized into two levels based on the amount.
*Clearance of oral residue was assessed by examining if gargling cleared any residues.
Plan to share IPD
none
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
multi-institutional joint research
Management information
Registered date
| 2018 | Year | 10 | Month | 16 | Day |
Last modified on
| 2020 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039275
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| Research case data specifications | |
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| Registered date | File name |
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