UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027040 |
|---|---|
| Receipt number | R000030995 |
| Scientific Title | Investigation of the deviation of trachea, bronchi, and diaphragm with position change |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2017/09/05 15:24:58 |
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Basic information
Public title
Investigation of the deviation of trachea, bronchi, and diaphragm with position change
Acronym
Investigation of the deviation of trachea, bronchi, and diaphragm with position change
Scientific Title
Investigation of the deviation of trachea, bronchi, and diaphragm with position change
Scientific Title:Acronym
Investigation of the deviation of trachea, bronchi, and diaphragm with position change
Region
| Japan |
Condition
Condition
healthy adult volunteers
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the deviation of trachea, bronchi, and diaphragm after turning from supine to lateral position in healthy volunteers.
Basic objectives2
Others
Basic objectives -Others
To examine the deviation of trachea, bronchi, and diaphragm.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Deviation of trachea, bronchi, and diaphragm
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Chest radiography in supine position
Interventions/Control_2
Chest radiography in lateral position
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy male or female volunteers with prior written consent, aged from 20 to70
Key exclusion criteria
1.Known or possible pregnancy
2.Subjects who do not provide written informed consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Ubukata |
Organization
Ebara Hospital
Division name
Department of Anesthesiology
Zip code
Address
4-5-10 Higashiyukigaya, Ota-ku, Tokyo, Japan
TEL
03-5734-8000
yuusuke-ubukata1@tokyo-hmt.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Ubukata |
Organization
Ebara Hospital
Division name
Department of Anesthesiology
Zip code
Address
4-5-10 Higashiyukigaya, Ota-ku, Tokyo, Japan
TEL
03-5734-8000
Homepage URL
yuusuke-ubukata1@tokyo-hmt.jp
Sponsor or person
Institute
Department of Anesthesiology, Ebara Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2017 | Year | 05 | Month | 01 | 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
| 2017 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 18 | Day |
Last modified on
| 2017 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030995
