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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033011
Receipt No. 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

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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
Email 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
Email norisue.yasuhiro@gmail.com

Sponsor
Institute Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037632

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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