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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038088
Receipt No. R000043408
Scientific Title Squatting test-2
Date of disclosure of the study information 2020/01/01
Last modified on 2019/09/24

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Basic information
Public title Development and evaluation of a new method to determine baroreflex sensitivity, and its application to clinical investigations
Acronym Development of a new method for baroreflex determination
Scientific Title Squatting test-2

Scientific Title:Acronym Squatting test-2
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Anesthesiology Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the hypothesis that baroreflex sensitivity determined by the squatting test correlates with those determined by the Oxford method, spontaneous sequence method, and Valsalva method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlations between baroreflex sensitivity determined by the squatting test vs. those of the Oxford method, spontaneous sequence method, and Valsalva test.
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Intravenous access is established, and the blood pressure is increased and decreased by intravenous phenylephrine and nitroprusside, respectively.
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
65 years-old >
Gender Male and Female
Key inclusion criteria healthy volunteers without medication
Key exclusion criteria Subjects with a history of cardiovascular, respiratory or metabolic disorders are excluded
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Tanaka
Organization University of Tsukuba, faculty of medicine
Division name Department of Anesthesiology
Zip code 305-8575
Address Tennoudai 1-1-1, Tsukuba-city, Ibaraki-ken
TEL 029-853-3285
Email mtanaka@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Tanaka
Organization University of Tsukuba, faculty of medicine
Division name Department of Anesthesiology
Zip code 305-8575
Address Tennoudai 1-1-1, Tsukuba-city, Ibaraki-ken
TEL 029-853-3285
Homepage URL
Email mtanaka@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports and Science
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 Tsukuba Clinical Research and Development Organization
Address Amakuba 2-1-1, Tsukuba-city, Ibaraki-ken
Tel 029-853-3914
Email igawa.junko.fu@un.tsukuba.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
2020 Year 01 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 30 Day
Date of IRB
2019 Year 09 Month 18 Day
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2020 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
2019 Year 09 Month 24 Day
Last modified on
2019 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043408

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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