UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044015 |
|---|---|
| Receipt number | R000050262 |
| Scientific Title | Effect of intraoperative repositioning on Central Venous Pressure (CVP) and Stroke Volume Variation (SVV) |
| Date of disclosure of the study information | 2021/05/17 |
| Last modified on | 2021/05/17 11:39:13 |
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Basic information
Public title
Effect of intraoperative repositioning on Central Venous Pressure (CVP) and Stroke Volume Variation (SVV)
Acronym
About the effect of intraoperative postural change on CVP and SVV
Scientific Title
Effect of intraoperative repositioning on Central Venous Pressure (CVP) and Stroke Volume Variation (SVV)
Scientific Title:Acronym
About the effect of intraoperative postural change on CVP and SVV
Region
| Japan |
Condition
Condition
Patients who underwent hepatectomy
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Anesthesiology |
| Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify the degree of influence (whether or not there is a correlation between the rate of change of CVP value and SVV value) on the fluctuation of CVP value and SVV value due to postural change performed during hepatectomy.
Clarify whether SVV can be used as an alternative index of CVP and whether the fluctuation range of CVP due to postural change can be predicted from SVV.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
With 0 degree as the reference value, evaluate the correlation between the rate of change of CVP and SVV due to intraoperative postural change (5 degree and 10 degree ) using linear regression analysis.
Key secondary outcomes
If the SVV value does not show a large change due to the postural change, the estimation of the CVP change rate in the SVV eigenvalue and the identification of the factors that influence the change due to the postural change of CVP / SVV are verified as secondary evaluation items. In the statistical analysis method, regarding the estimation of the CVP change rate in the SVV eigenvalue, the CVP change rate in the SVV value for each case is obtained, evaluated by performing linear regression analysis, and the factors that influence the fluctuation due to the position change of CVP / SVV. Identification is evaluated by performing multivariate analysis using preoperative information or information obtained during surgery as explanatory variables.
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Postural change during hepatectomy
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
1: Patients who undergo hepatectomy as scheduled surgery (no provisions are made based on age, gender, target disease, or presence or absence of prior treatment)
2: Patients in whom a central venous catheter capable of CVP measurement is inserted and indwelled during surgery, and a Flo TracTM Sensor is connected to the arterial indwelling catheter so that SVV can be calculated.
3: Patients aged 20 years or older at the time of consent acquisition.
4: Patients who received sufficient explanation and fully understood when participating in this study, and obtained written consent by the patient himself / herself.
Key exclusion criteria
1: Patients with unstable hemodynamics at the time of induction of anesthesia (shock index> 1)
2: Patients with severe aortic regurgitation or atrial fibrillation (because the analysis result by Flo TracTM Sensor becomes unstable)
3: Patients judged by the investigator to be inappropriate as subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Koizumi |
Organization
St. Marianna University Hospital
Division name
Department of Gastroenterological and General Surgery
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi,Kanagawa pref, Japan
TEL
044-977-8111
satoshi.koizumi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiyoshi |
| Middle name | |
| Last name | Masuda |
Organization
St. Marianna University Hospital
Division name
Department of Gastroenterological and General Surgery
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi,Kanagawa pref, Japan
TEL
044-977-8111
Homepage URL
akiyoshi.masuda@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of St. Marianna University Hospital
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi,Kanagawa pref, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
| 2021 | Year | 05 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 22 | Day |
Last modified on
| 2021 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050262
