UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014975 |
|---|---|
| Receipt number | R000017429 |
| Scientific Title | Development of evaluation system for cough ability |
| Date of disclosure of the study information | 2014/08/28 |
| Last modified on | 2023/09/07 16:05:55 |
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Basic information
Public title
Development of evaluation system for cough ability
Acronym
Development of evaluation system for cough ability
Scientific Title
Development of evaluation system for cough ability
Scientific Title:Acronym
Development of evaluation system for cough ability
Region
| Japan |
Condition
Condition
Normal adult
Respiratory disease patients
Classification by specialty
| Pneumology | Laboratory medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To simulate the cough expiratory flow wave by using some resting parameters
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expiratory flow wave during cough
Key secondary outcomes
Cough peak flow
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal adult
Respiratory disease patients
Key exclusion criteria
Without normal adult and respiratory disease patients
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Tabira |
Organization
Kio University
Division name
Division of Health Science, Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL
0745-54-1601
k.tabira@kio.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Tabira |
Organization
Kio University
Division name
Division of Health Science, Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL
0745-54-1601
Homepage URL
k.tabira@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review committee of Kio University
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
Tel
0745-54-1602
soumu@kio.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
26350644
Org. issuing International ID_1
Grant-in-Aid for Scientific Research (KAKENHI)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
畿央大学（奈良県） Kio University
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Lung and chest wall compliance at rest are measured using a flow meter and an esophagus balloon catheter.
Airway resistance, pleural pressure, and cough expiratory flow are measured at maximum inspiratory volume.
We simulate the cough expiratory flow by using the capacitor discharge model and equal pressure point (EPP) theory.
Management information
Registered date
| 2014 | Year | 08 | Month | 28 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017429
