UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016290 |
|---|---|
| Receipt number | R000018899 |
| Scientific Title | An open labeled randomized comparative study of newly developed inflationary non-invasive blood pressure monitor (NIBP) and conventional deflationary NIBP in measuring clinical hypotension |
| Date of disclosure of the study information | 2015/01/22 |
| Last modified on | 2018/03/24 23:48:59 |
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Basic information
Public title
An open labeled randomized comparative study of newly developed inflationary non-invasive blood pressure monitor (NIBP) and conventional deflationary NIBP in measuring clinical hypotension
Acronym
A comparative study of inflationary NIBP and deflationary NIBP in measuring clinical hypotension
Scientific Title
An open labeled randomized comparative study of newly developed inflationary non-invasive blood pressure monitor (NIBP) and conventional deflationary NIBP in measuring clinical hypotension
Scientific Title:Acronym
A comparative study of inflationary NIBP and deflationary NIBP in measuring clinical hypotension
Region
| Japan |
Condition
Condition
Cardiovascular surgery which used cardiopulmonary bypass
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine whether an inflationary NIBP can quickly measure blood pressure below 80 mmHg compared with a conventional deflationary NIBP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time required to measure blood pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group: NIBP is measured with an inflationary method.
Duration of intervention: during general anesthesia
Interventions/Control_2
Control group: NIBP is measured with a conventional deflationary method.
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 patients who scheduled for elective cardiovascular surgery under cardiopulmonary bypass
Key exclusion criteria
1.Patients with obvious vascular lesion in upper or lower extremities
2.Patients who have a hemodialysis shunt
3.Patients who have bilateral difference in NIBP of upper extremities
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akari Yoshida |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
Address
811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan
TEL
073-441-0611
akari.firefly@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akari Yoshida |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
Address
811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan
TEL
073-441-0611
Homepage URL
akari.firefly@gmail.com
Sponsor or person
Institute
Wakayama Medical University
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
NIHON KOHDEN CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 22 | 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
| 2015 | Year | 01 | Month | 21 | Day |
Last modified on
| 2018 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018899
