UMIN-CTR Clinical Trial

Basic information
Public title	the accuracy evaluation of the iNIBP and the pain evaluation of the YAWARACUFF2
Acronym	the accuracy evaluation of the iNIBP and the pain evaluation of the YAWARACUFF2
Scientific Title	the accuracy evaluation of the iNIBP and the pain evaluation of the YAWARACUFF2
Scientific Title:Acronym	the accuracy evaluation of the iNIBP and the pain evaluation of the YAWARACUFF2
Region	Japan

Condition
Condition	healthy volunteers
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will evaluate the accuracy of the inibp using the mercury manometers and the degree of the pain using nibp
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	systolic blood pressure diastolic blood pressure the degree of the pain using NRS
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	we will collect 30 volunteers, we will evaluate the accuracy of the inibp we will evaluate their blood pressures in the way of ISO 81060-2;2013
Interventions/Control_2	Second,we will evaluate the degree of the pain of the place which was attached the cuff using NRS. we will make 2 papers which were written the alphabet g, h. g:inibp,nibp h:nibp,inibp the volunteers will take one in the enveloped papers.we will evaluate their blood pressures in these procedures.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	the volunteers who can accept the consent of this research.
Key exclusion criteria	the principal investigator, the sharer
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Yasuhisa Middle name Last name Okuda
Organization	dokkyo medical university Saitama medical center
Division name	anesthesiology
Zip code	343-8555
Address	2-1-50,Minami koshigaya, Koshigaya city, Saitama
TEL	+81-4-8965-1111
Email	y-okuda@dokkyomed.ac.jp

Public contact
1st name of contact person	1st name Kei Middle name Last name Takahashi
Organization	dokkyo medical university saitama medical center
Division name	anesthesiology
Zip code	343-8555
Address	2-1-50,Minami koshigaya, Koshigaya city, Saitama
TEL	+81-4-8965-1111
Homepage URL
Email	kkk14364@yahoo.co.jp

Sponsor
Institute	dokkyo medical university saitama medical center
Institute
Department

Funding Source
Organization	dokkyo medical university saitama medical center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	dokkyo medical university saitama medical center
Address	2-1-50 Minamikoshigya Koshigaya-city Saitama-Ken
Tel	048-965-0658
Email	m-iyama@dokkyomed.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	2017 Year 04 Month 04 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	Completed
Date of protocol fixation	2017 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date	2017 Year 04 Month 10 Day
Last follow-up date	2018 Year 08 Month 13 Day
Date of closure to data entry	2018 Year 08 Month 13 Day
Date trial data considered complete	2018 Year 08 Month 13 Day
Date analysis concluded	2018 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date	2017 Year 04 Month 03 Day
Last modified on	2019 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030745