UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021570 |
|---|---|
| Receipt number | R000023364 |
| Scientific Title | Noninvasive measurement of hemodynamic status by oscillometric method |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2018/12/26 17:14:22 |
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Basic information
Public title
Noninvasive measurement of hemodynamic status by oscillometric method
Acronym
Noninvasive measurement of hemodynamic status by oscillometric method
Scientific Title
Noninvasive measurement of hemodynamic status by oscillometric method
Scientific Title:Acronym
Noninvasive measurement of hemodynamic status by oscillometric method
Region
| Japan |
Condition
Condition
Adult elective surgery patient(over 20 years old)
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The validation for conventional way of the new measurement method of pulse pressure variation(PPV) and central venous pressure(CVP)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The estimation of error between estimated PPV and measured PPV.
The estimation of error between estimated CVP and measured CVP.
Key secondary outcomes
Safety of our method.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Duration: During the stay in operating room.
Frequency: 12 times or more at 10 minutes or more intervals.
Head down or head up of operating table. (Each maneuver performed once)
Interventions/Control_2
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
Patients who are planned measuring arterial pressure by arterial catheter or are planned measuring central venous pressure.
Patients who are informed enough and presents the will of participation to this study by written form.
Key exclusion criteria
Patients who are unsuitable for attaching the pressure cuff at both upper arms by reason of surgical procedure or physical impairment.
Patients who withdraw his informed consent.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Kawamoto |
Organization
Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
Address
1-2-3,Kasumi,Minami-ku,Hiroshima
TEL
81-082-256-3234
anekawa@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuji Nakamura |
Organization
Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
Address
1-2-3,Kasumi,Minami-ku,Hiroshima
TEL
81-082-256-3234
Homepage URL
r-nacamura@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care, Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
広島大学病院(広島県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | 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
| 2016 | Year | 03 | Month | 22 | Day |
Last modified on
| 2018 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023364
