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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name