UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038088 |
|---|---|
| Receipt number | R000043408 |
| Scientific Title | Squatting test-2 |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2019/09/24 10:47:03 |
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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
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
mtanaka@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043408
