UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of subcutaneous bleeding during non-invasive blood pressure monitoring
Title of the study (Brief title)	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	Yasuhiro Morimoto
Organization	Ube Industries Central Hospital
Division name	Anesthesiology
Address	750 Nishikiwa Ube Yamaguchi
TEL	0836-51-9221
Email	yasumorimo@gmail.com

Public contact
Name of contact person	Yasuhiro Morimoto
Organization	Ube Industries Central Hospital
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027277