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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023685
Receipt No. 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

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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
Last 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
Email yasumorimo@gmail.com

Public contact
1st 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
Email yasumorimo@gmail.com

Sponsor
Institute Ube Industries Central Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027277

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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