UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033011 |
|---|---|
| Receipt number | R000037632 |
| Scientific Title | Cough strength predicted by diaphragm ultrasonography in healthy volunteers |
| Date of disclosure of the study information | 2018/06/15 |
| Last modified on | 2019/06/16 09:12:24 |
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Basic information
Public title
Cough strength predicted by diaphragm ultrasonography in healthy volunteers
Acronym
Cough strength and diaphragm ultrasonography
Scientific Title
Cough strength predicted by diaphragm ultrasonography in healthy volunteers
Scientific Title:Acronym
Cough strength and diaphragm ultrasonography
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of diaphragm ultrasonographic indices to predict cough strength
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cough expiratory peak flow
Diaphragm excursion measured by M-mode
Diaphragm maximum velocity by tissue doppler
Other ultrasonographic indices
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers
Key exclusion criteria
Medical history of pulmonary diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Norisue |
Organization
Emergency and critical care medicine
Division name
Division of critical care
Zip code
279-0001
Address
3-4-32 Todaijima, Urayasushi, Chiba, Japan
TEL
047-351-3101
norisue.yasuhiro@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Norisue |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Division of critical care
Zip code
279-0001
Address
3-4-32 Todaijima, Urayasushi, Chiba, Japan
TEL
047-351-3101
Homepage URL
norisue.yasuhiro@gmail.com
Sponsor or person
Institute
Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
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
Tokyo Bay Urayasu Ichikawa Medical Center
Address
Yokohama, Japan
Tel
047-351-3101
norisue.yasuhiro@gmail.com
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
| 2018 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
http://rc.rcjournal.com/content/early/2019/05/21/respcare.06780
Publication of results
Published
Result
URL related to results and publications
http://rc.rcjournal.com/content/early/2019/05/21/respcare.06780
Number of participants that the trial has enrolled
56
Results
Passive cephalic excursion of the diaphragm during the cough expiratory phase significantly predicted CPF with maximum cough effort in healthy adults. Future studies should investigate the relationship between CPF and excursion in persons with respiratory and neuromuscular disorders.
Results date posted
| 2019 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy volunteers
Participant flow
N/A
Adverse events
None
Outcome measures
cough peak flow
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2018 | Year | 06 | Month | 15 | Day |
Last modified on
| 2019 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037632
| 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 |
