UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040452 |
|---|---|
| Receipt number | R000045954 |
| Scientific Title | Non-invasive blood pressure when the cuff direction is reversed |
| Date of disclosure of the study information | 2020/05/19 |
| Last modified on | 2024/12/30 10:27:20 |
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Basic information
Public title
Non-invasive blood pressure when the cuff direction is reversed
Acronym
Non-invasive blood pressure when the cuff direction is reversed
Scientific Title
Non-invasive blood pressure when the cuff direction is reversed
Scientific Title:Acronym
Non-invasive blood pressure when the cuff direction is reversed
Region
| Japan |
Condition
Condition
Healthy young adult
Classification by specialty
| Anesthesiology | Operative medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Check the equivalence of non-invasive blood pressure measurements due to different directions of the cuff.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The non-invasive blood pressure measurements due to different directions of the cuff
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy young adults who can measure non-invasive blood pressure with the left and right upper arms
Key exclusion criteria
When non-invasive blood pressure could not be measured at one time, arrhythmia, extremely low blood pressure or extremely high blood pressure
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koh |
| Middle name | |
| Last name | Mizutani |
Organization
Osaka Rosai Hospital
Division name
Department of Anesthesia
Zip code
591-8025
Address
1179-3 Nagasonecho, Kita-ku, Sakai 591-8025 Japan
TEL
072-252-3561
mizutani@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Koh |
| Middle name | |
| Last name | Mizutani |
Organization
Osaka Rosai Hospital
Division name
Department of Anesthesia
Zip code
591-8025
Address
1179-3 Nagasonecho, Kita-ku, Sakai 591-8025 Japan
TEL
072-252-3561
Homepage URL
mizutani@osakah.johas.go.jp
Sponsor or person
Institute
Osaka Rosai 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
Osaka Rosai Hopital
Address
1179-3 Nagasonecho, Kita-ku, Sakai 591-8025 Japan
Tel
072-252-3561
mizutani@osakah.johas.go.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
大阪労災病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
https://kenkyuukai.m3.com/journal/journal_contents.asp?j_type=0&id=3830&co_id=55382&s_id=815&file=1
Publication of results
Partially published
Result
URL related to results and publications
https://kenkyuukai.m3.com/journal/journal_contents.asp?j_type=0&id=3830&co_id=55382&s_id=815&file=1
Number of participants that the trial has enrolled
33
Results
https://kenkyuukai.m3.com/journal/journal_contents.asp?j_type=0&id=3830&co_id=55382&s_id=815&file=1
Results date posted
| 2022 | Year | 05 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://kenkyuukai.m3.com/journal/journal_contents.asp?j_type=0&id=3830&co_id=55382&s_id=815&file=1
Participant flow
https://kenkyuukai.m3.com/journal/journal_contents.asp?j_type=0&id=3830&co_id=55382&s_id=815&file=1
Adverse events
https://kenkyuukai.m3.com/journal/journal_contents.asp?j_type=0&id=3830&co_id=55382&s_id=815&file=1
Outcome measures
https://kenkyuukai.m3.com/journal/journal_contents.asp?j_type=0&id=3830&co_id=55382&s_id=815&file=1
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A healthy surgery staff member is enroled as a subject, and a manchette is put in normal direction on one upper arm and the other side is put in the opposite direction. We prepare two blood pressure monitors of the same model and measure simultaneously. Immediately, put both manchettes in reverse again, and measure simultaneously. We compare the systolic and diastolic blood pressure values.
Management information
Registered date
| 2020 | Year | 05 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045954
