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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024558
Receipt No. R000028263
Scientific Title Effect of left and right recumbent positions on hemodynamics in healthy adults by using MRI
Date of disclosure of the study information 2016/12/01
Last modified on 2019/04/03

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Basic information
Public title Effect of left and right recumbent positions on hemodynamics in healthy adults by using MRI
Acronym Effect of recumbent positions on hemodynamics
Scientific Title Effect of left and right recumbent positions on hemodynamics in healthy adults by using MRI
Scientific Title:Acronym Effect of recumbent positions on hemodynamics
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the influence of left and right recumbent positions on hemodynamics in healthy adults.
Basic objectives2 Others
Basic objectives -Others Not applicable
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Changes in hemodynamics in supine, left recumbent and right recumbent positions.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 MRI study is performed once in supine, left recumbent and right recumbent positions.
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
50 years-old >
Gender Male and Female
Key inclusion criteria No history of respiratory or cardiovascular diseases
Taking no regular medications
Key exclusion criteria Obesity (BMI over 30)
Adults with claustrophobia
Pregnant adults
Adults under 20 of age
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Konosuke
Middle name
Last name Sasaki
Organization Tohoku University Graduate School of Medicine
Division name Cardiovasuclar surgery
Zip code 9818574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7226
Email konosuke.s@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Konosuke
Middle name
Last name Sasaki
Organization Tohoku University Graduate School of Medicine
Division name Cardiovasuclar surgery
Zip code 9818574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7226
Homepage URL
Email konosuke.s@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization North Japan Academy of Nursing Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University School of Medicine, IRB
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.ac.jp

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
2016 Year 12 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 12
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 No longer recruiting
Date of protocol fixation
2017 Year 05 Month 01 Day
Date of IRB
2016 Year 10 Month 24 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 25 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028263

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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