UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026833
Receipt number R000030745
Scientific Title the accuracy evaluation of the iNIBP and the pain evaluation of the YAWARACUFF2
Date of disclosure of the study information 2017/04/04
Last modified on 2019/04/23 08:48:44

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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

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

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 or person

Institute

dokkyo medical university saitama medical center

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030745


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name