UMIN-CTR Clinical Trial
| 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 (Ver. 4) |
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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 |
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| Condition | |||
| Condition | Healthy volunteers | ||
| Classification by specialty |
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| 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 | |
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| Purpose of intervention | |
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| Interventions/Control_1 | |
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| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | Healthy volunteers | |||
| Key exclusion criteria | Medical history of pulmonary diseases | |||
| Target sample size | 50 | |||
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| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 |
| 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 | |
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| Date of disclosure of the study information |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Healthy volunteers |
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| Participant flow | N/A |
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| Adverse events | None |
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| Outcome measures | cough peak flow |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Date analysis concluded | |||||||
| Other | |
| Other related information | Not applicable |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037632 |
