UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023685 |
|---|---|
| Receipt number | R000027277 |
| Scientific Title | Evaluation of subcutaneous bleeding during non-invasive blood pressure monitoring |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2017/08/22 15:37:55 |
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Basic information
Public title
Evaluation of subcutaneous bleeding during non-invasive blood pressure monitoring
Acronym
Evaluation of subcutaneous bleeding
Scientific Title
Evaluation of subcutaneous bleeding during non-invasive blood pressure monitoring
Scientific Title:Acronym
Evaluation of subcutaneous bleeding
Region
| Japan |
Condition
Condition
blood pressure monitoring
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Decreasing of subcutaneous bleeding during the non-invasive blood pressure monitoring
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of subcutaneous bleedin
Key secondary outcomes
Pain during the blood pressure monitoring
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
non-invasive blood pressure monitoring
Interventions/Control_2
Changing the blood pressure cuff
Interventions/Control_3
Changing the mesuring method
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Volunteer
Key exclusion criteria
non
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Morimoto |
Organization
Ube Industries Central Hospital
Division name
Anesthesiology
Zip code
Address
750 Nishikiwa Ube Yamaguchi
TEL
0836-51-9221
yasumorimo@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Morimoto |
Organization
Ube Industries Central Hospital
Division name
Anesthesiology
Zip code
Address
750 Nishikiwa Ube Yamaguchi
TEL
0836-51-9221
Homepage URL
yasumorimo@gmail.com
Sponsor or person
Institute
Ube Industries Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Ube Industries Central Hospital
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
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | 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
| 2016 | Year | 08 | Month | 19 | Day |
Last modified on
| 2017 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027277
