UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022660 |
|---|---|
| Receipt number | R000026106 |
| Scientific Title | Researching accuracy of Stroke Volume Variation (SVV) in spontaneous breathing |
| Date of disclosure of the study information | 2016/06/08 |
| Last modified on | 2022/06/13 12:25:34 |
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Basic information
Public title
Researching accuracy of Stroke Volume Variation (SVV) in spontaneous breathing
Acronym
Researching accuracy of SVV in spontaneous breathing
Scientific Title
Researching accuracy of Stroke Volume Variation (SVV) in spontaneous breathing
Scientific Title:Acronym
Researching accuracy of SVV in spontaneous breathing
Region
| Japan |
Condition
Condition
Abdominal Aortic Aneurysm
Classification by specialty
| Vascular surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We research that patients monitoring with Flo Trac system can measure accurate SVV in spontaneous breathing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of SVV between positive pressure ventilation and 6 times/min , 15 times/min spontaneous breathing
Key secondary outcomes
Difference of SVV between 15 times/min spontaneous breathing and 6 times/min spontaneous breathing
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Targets are 20 years of age or older patients doing elective surgery of abdominal aortic aneurysm.
Operation is branch type artificial blood vessel replacement surgery.
These patients monitor with Flo Trac system.
Key exclusion criteria
Patients with
moderate or severe aortic valve stenosis
or moderate or severe mitral valve regurgitation
or intra-aortic balloon pimping
or percutaneous cardiopulmonary support
or ventricular assist device.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Toyama |
Organization
Tohoku University Hospital
Division name
Anesthesiology
Zip code
980-8574
Address
Seiryomachi, Aoba-ku Sendai-shi, Miyagi, 980-8574
TEL
022-717-7321
toru.tamii.b6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Tamii |
Organization
Tohoku University Hospital
Division name
Anesthesiology
Zip code
980-8574
Address
Seiryomachi, Aoba-ku Sendai-shi, Miyagi, 980-8574
TEL
022-717-7321
Homepage URL
rg7.db10.zz10@gmail.com
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
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
Tohoku University Hospital
Address
Seiryomachi, Aoba-ku Sendai-shi, Miyagi, 980-8574
Tel
022-717-7321
rg7.db10.zz10@gmail.com
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
| 2016 | Year | 06 | Month | 08 | 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
| 2016 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None notices
Management information
Registered date
| 2016 | Year | 06 | Month | 08 | Day |
Last modified on
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026106
