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
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
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
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
