UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041825 |
|---|---|
| Receipt number | R000047429 |
| Scientific Title | Effect of flow rate difference of high-flow nasal cannula on the swallowing function |
| Date of disclosure of the study information | 2020/09/18 |
| Last modified on | 2020/09/17 16:15:39 |
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Basic information
Public title
Effect of flow rate difference of high-flow nasal cannula on the swallowing function
Acronym
Effect of high-flow nasal cannula on the swallowing function
Scientific Title
Effect of flow rate difference of high-flow nasal cannula on the swallowing function
Scientific Title:Acronym
Effect of high-flow nasal cannula on the swallowing function
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to clarify the impact of different HFNC flow rates on swallowing function.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-mL water swallow test
Key secondary outcomes
repetitive saliva swallowing test
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
| 22 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy volunteers were confirmed to be able to swallow more than three times per 30 seconds by the RSST.
Key exclusion criteria
1) aspiration pneumonia
2) pulmonary disorder
3) cerebrovascular diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Arizono |
Organization
Seirei Christopher University
Division name
School of Rehabilitation Sciences
Zip code
433-8558
Address
3453 Mikataha Kitaku, Hamamatsu
TEL
053-439-1400
arizono-s@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Arizono |
Organization
Seirei Christopher University
Division name
School of Rehabilitation Sciences
Zip code
433-8558
Address
3453 Mikataha Kitaku, Hamamatsu
TEL
053-439-1400
Homepage URL
arizono-s@umin.ac.jp
Sponsor or person
Institute
Seirei Christopher University
Institute
Department
Personal name
Funding Source
Organization
Seirei Christopher University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Mikatahara General Hospital
Address
3453 Mikataha Kitaku, Hamamatsu
Tel
0534391400
shinichi-a@seirei.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 18 | Day |
Related information
URL releasing protocol
https://erj.ersjournals.com/content/46/suppl_59/PA4199
Publication of results
Partially published
Result
URL related to results and publications
https://erj.ersjournals.com/content/46/suppl_59/PA4199
Number of participants that the trial has enrolled
30
Results
Five subjects choked at both 40 and 50 L/min during the WST.
Results date posted
| 2020 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
29.9years
%VC:104.2%
FEV1.0%:86.8%
Participant flow
Thirty subjects were enrolled.
no patients were drop out
Thirty subjects were completed in this study.
Adverse events
no
Outcome measures
WST
RSST
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the present study, we aimed to test our hypothesis that increased High-flow nasal cannula therapy flow rate negatively impacts swallowing function and effort in healthy volunteers.
Management information
Registered date
| 2020 | Year | 09 | Month | 17 | Day |
Last modified on
| 2020 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047429
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
